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Investor Update

Sep 24, 2019

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Okay, let's get started. Welcome to Medtronic's Robotic Assisted Surgery Analyst Update here in Hartford, Connecticut. It's great to see such a full room here today. Really appreciate all of you making the trip here to Hartford. Thank you as well to the hundreds online right now listening to the webcast around the world. I'm Ryan Weispfenning, Vice President at Medtronic and Head of Investor Relations. Today we're going to be making some forward-looking statements as well as some statements about some products that are still pre-market. I'll just take a minute here for you to take a look at the statements here on the slides pertaining to forward-looking statements and regulatory disclaimers. These are available on our website, investorrelations.medtronic.com, and I encourage you to read these statements. Important today, I want to make sure you're aware of this.

We're not allowing any photography in the room, no video recording. Please put down your phones, put down your video recording devices. If you're caught taking pictures, unfortunately, they're going to come and ask you to leave. Please, I want all of us to enjoy the event today. I want you to be able to stay here and participate in it. Please, no video recording, no photography. This is the start of a very busy week for us here at Medtronic, starting today here with our Minimally Invasive Therapies Group management team here in Hartford. Tomorrow, we'll be at the North American Spine Society Conference in Chicago with our Restorative Therapies Group leadership team. On Thursday, we're on the West Coast in San Francisco for TCT, and we'll have our Cardiac and Vascular Group management team.

You'll get to hear from three of our core groups at Medtronic over the course of the week. I look forward to seeing those of you that make the trip from here to Chicago and on to San Francisco. If you can't attend in person, we will be webcasting all of the events this week on our website at investorrelations.medtronic.com. We've planned an eventful afternoon for you today. First, we will have a management presentation, and that'll be followed by a live look-in into the operating room just next door here to see the setup and draping of the robot. We'll have a panel of expert surgeons to talk about their experience, and we'll be able to take your questions as well at that point. After that, we'll move to the live surgery portion of the event this afternoon.

For the sell side analysts that cover Medtronic or the person that they designated, if you previously completed your consent forms, you probably noticed on your badge you have a lab designation on your badge. We'll take those people down into the operating room for the live surgery so they can be in the room to see that. For all the rest of us, we're actually going to have a really good view watching it on the big screen here in the room. Then we'll end the day by assembling a panel of Medtronic management to answer your questions. With that, I'd like to invite up Mike Weinstein. Mike is the Senior Vice President of Strategy at Medtronic. Mike?

Mike Weinstein
SVP of Strategy, Medtronic

Thank you, Ryan, welcome everybody to Hartford. I just want a couple of items before we get fully into our agenda, which Ryan introduced you to today. First is really one, why are we here? As you're aware, for competitive reasons, we've kept our soft tissue robotics program close to the vest. As we move into the commercialization phase and start placing robots in countries around the globe, starting in the second half of this fiscal year, we didn't want to put you in a position where you have to go chase around the globe to go see a Medtronic robot live and in action.

We also could have done this in a ballroom in New York and said, "Come in and see the robot," and you could have stared at an idle robot or maybe played with it as you might have years ago on an older system. That wouldn't be as interesting as actually seeing it live and in use and talking to surgeons that have been a part of the development process and are using it here today. I think this is going to be a really great event. Again, thank you everybody for traveling to Hartford. I know it wasn't necessarily convenient for everybody, but I think it'll be a day well spent. Second, the focus of today is on our robotics program, but I would be remiss if I didn't take the opportunity to really spotlight the breadth of our pipeline across the entire company right now.

As excited as we are about robotics, and you're going to hear that consistently throughout the day today, it really is just one manifestation of the pipeline that you've heard Omar talking about on the last few earnings calls. Omar's described it as the strongest pipeline in the company's history, and I really believe that. The good news today as I stand in front of you is that that pipeline is now coming to fruition. I won't cover everything that we're working on, but take a look at what we have coming over just the next 12 months. It's incredibly strong. In fact, just think about the last few weeks of the news flow that you've heard from Medtronic. We got FDA approval for our TAVR low risk indication. We launched our Midas Rex MR8 next generation drill system.

We presented compelling AV access data for our IN.PACT Admiral drug-coated balloon, showing a 56% reduction in the need for re-intervention, which is 2x the rate for the competing product, which is on the market today. We just announced earlier this week FDA approval for our TAVR Evolut PRO+, our next generation TAVR system, launching with that low-risk indication this week at the TCT conference, which I know a number of you are going to. As we look forward over the next 12 months, it just gets stronger. Over the coming months, we're anticipating regulatory approval and launches of our LINQ II implantable cardiac monitor, our breakthrough and market-disruptive Micra AV leadless pacing system. In diabetes, our 780G advanced hybrid closed-loop system. In pelvic health, our 3cc sacral neuromodulation system. That's 3cc versus our market-leading 15cc device today.

In deep brain stimulation, we'll introduce for the first time a deep brain stimulator that has the ability to sense the electrical activity in the brain, putting us on a pathway for a closed-loop deep brain stimulation system, which we think is going to be a major leap forward in the technology and the therapy. In addition to some of these launches, as well as others you can see here up on the screen, we have a long list of clinical trial readouts, including the pivotal trial results of our Symplicity renal denervation system, our 780G advanced hybrid closed-loop system, and our DiamondTemp AF RF ablation catheter, marking our entry into the $2.5 billion RF focal ablation market. Again, this is just the next 12 months, and as you can tell, I couldn't be more excited. Let me turn it over to Bob, Megan, and the MITG team.

For those of you that don't know Bob, he took the reins of the MITG business about 21 months ago, and really has led not only the advancement of the robotics program to where it is today, and you're going to obviously see that and hear a lot about it, but the performance of a business that has been exceptional. Our MITG business in FY 2019 grew 5.8%. It's off to a really strong start in FY 2020. You'll recall last month on our first quarter earnings call, we raised the guidance for the MITG business for the year. You've got a team in Bob, Megan, and the rest of the MITG team. I should say, Megan took over the robotics program just after Bob took over MITG.

You've got a team that's been executing on the business quarter after quarter while making this big investment in this huge program as robotics. I won't take any more of your time today. I'm now going to hand the reins over to Bob White, President of Medtronic's MITG business. Bob.

Bob White
President of MITG Business, Medtronic

Thanks, Mike. Good afternoon, everyone. Let me extend my very warm welcome to you coming to Hartford today. It is appropriate that we are in Hartford and at Hartford Hospital. The MITG colleagues around the world, every day, spend time with surgeons and administrators. I also want to give a big thank you to the folks and the staff at Hartford Hospital, not just for this event, which I think you will be most pleased, but really for the years of collaboration on our robotics program that you will see today. What you are going to see, as Mike alluded to, is you are going to see a cadaveric procedure, which is absolutely part and parcel of our pilot pre-clinical work for our validation and verification testing. That is what you are going to see. We are going to walk through that in a little bit.

Before I do, I want to introduce you to a few members of my team who will be joining me throughout the course of the day, and I'll ask them just to come in front and give a quick wave. First, Megan. Megan, come on up. Megan is the Vice President and General Manager of our surgical robotics business. Real deep experience in MIS, legacy Covidien, but also a career that spans big capital in medical equipment, consumable, as well as disposable healthcare devices. You'll hear from Megan in a little bit as we talk through the features of the robot. Next, I'd ask Dr. Carla Peron to come up. Carla is the Chief Medical Officer of our surgical innovations business, an accomplished surgeon in her own right, and a very deep clinical researcher. Carla is actually going to be facilitating the surgeon panel.

You'll get to hear from Carla in just a bit. Third, I'd ask Tracy Accardi to come up. Tracy is the Vice President of Research and Development on our surgical robotics program. She's in scrubs because she's going to be leaving us and going to the operating room where we'll get to see her on the screen as she navigates it. Like my other colleagues, Tracy brings tremendously deep experience in healthcare, complex capital medical equipment devices, and I'm thrilled to have it. To my colleagues, thank you. You can go back and take a seat. Let's go ahead and get started. What I tried to do on a single page here is really describe what you're going to hear in the management presentation through three lenses.

We're going to talk about where we've been, we're going to talk about where we are today, then we're going to focus on where we're going. I'll unpack each of these three, but it's really important because where we've been and what we've pioneered in surgery is relevant to what we're going to bring to you in robotics. Where we are today, I want to dispel some myths today about how penetrated robotic-assisted surgery is. In fact, I'd ask you to write down one number, 2%. We're going to come back to that 2% number a lot through the course of today. Of course, we're going to spend time on our solution because there's real barriers in the market today that lead to only a 2% penetration, and that's cost and utilization.

We're going to come back to those barriers and specifically how our solution addresses those. Then, of course, as we move forward where we're going, I'm going to share a lot of details with you today. We're going to talk about key actions and progress and dates as we look forward. I'm also going to give you, once we do have an approved medical device, how we think about the financial impact of that on MITG. We'll come on to that as well. I won't leave you there. I'm also going to give you a glimpse into the future of where we're taking the robotics business. This is incredibly important because this isn't just about launching a robot, this is about building a robotics business, and I'll take you through how we see that evolving. That's the flow. I think you'll like it.

Let's unpack each one, beginning with our history of where we've been. This is really a story that begins in the 1960s when US Surgical was founded by Leon Hirsch. Leon, some of you will know, was both an innovator and an entrepreneur, and partnered with clinicians to solve at the time, which were tough surgical problems. Leon had a vision that he could invent a surgical stapler, and in fact, created balsa wood models in his garage. I want you to hold onto that image of a stapler reload made out of balsa wood, and I'm going to come back to that. That history of innovation, beginning with US Surgical, continued through Covidien, and now into Medtronic. It wasn't just continuous innovation, and I'll use an example of one category, if you will, in a minute.

We also honed our muscle in educating surgeons and their operating staff. That's a muscle that US Surgical, Covidien, and Medtronic now stand tall on. That's very important because what we do is, of course, bring new technologies to surgeons around the world. I want to bring this to full circle. If you look at the image on the right, that's actually Leon Hirsch. Leon is now in his 90s. We had him up to our lab, and what you'll find incredibly fascinating, I know I did, that's him firing a surgical stapler on our robot. It actually brought tears to Leon's eyes as he reflected back from the balsa wood models to now firing a surgical stapler on a robotic. That's a great story, but the punchline for you is really on the bottom of the chart.

If you look at the bottom of the chart and draw your eyes to the far right, this is the % of surgeries today that are done open, minimally invasive, and robotic-assisted. You can see open surgery, where the surgeon cuts you large cut down the middle, puts her hands in, fixes things, closes you back up. That's still 60% of the surgeries done today. Minimally invasive is about 30%-35%, and robotic-assisted surgery is less than 2% globally. That's that 2% number I'm going to ask you to keep in mind because we're going to keep coming back to that. That's it. Now let me take you one step further in terms of an innovation pipeline, and I just chose surgical stapling. I could have chosen advanced energy. I could have chosen a number of categories.

This is relevant because where we've been, you should expect to have applicability to where we're going in our surgical robot. You see in the '60s from the advent of surgical staplers through to the '70s and '80s when we introduced bariatric stapling to the first endoscopic stapler in the '90s. If you go to the bottom row, I draw your attention to the year 2010. That's when we first introduced Tri-Staple technology. Most of you in the room will know that Tri-Staple technology has been used in millions of procedure around the globe and is trusted by surgeons all over the world. You should absolutely anticipate that Tri-Staple technology that we've honed being available and planned for our robot, which you'll see here in a minute. The analog that I want you to think about here is actually Porsche.

If you think about Porsche, when Porsche decided to enter the electric car market, they came with them tremendous experience in automotive innovation. They had never built an electric car, but they understood automotive. We understand surgery as well as any company on the planet, and that's what we bring to the table. The reason we understand it so well is because we spend time with surgeons. In fact, we train over 9,000 surgeons a year on minimally invasive techniques. The so what for you is really twofold. One, you think about the depth of knowledge that we bring with our close collaboration with surgeons. We know what they want. We know what they need.

In fact, you'll hear from our surgeon panel in just a little bit. The second point is really important, and that is we have a global infrastructure already in place to train surgeons on all the new innovations that we bring to the marketplace. That's not something that's easily replicated, and it's already in place, and you can see the numbers. We do it really well. What we train them on is minimally invasive surgery. The reason that is so important is we understand that minimally invasive surgery, as opposed to open surgery, has real benefits. Right? You can see from the slide, fewer complications, shorter hospital stay, faster recovery, and an overall less cost to the system. In fact, it's one of those unusual things that's good for the patient, good for the doctor, good for the provider, and good for the payer.

The point I want to make on this slide that's really important that you understand is every 1% shift from open to minimally invasive surgery unlocks a $200 million market opportunity, and that's before robotics. Think about the magnitude and why we're so focused on advancing minimally invasive surgery. A single percentage shift unlocks $200 million of market opportunity. Certainly would ask you to keep that in mind. I think it's a nice pivot to think about, well, how does robotic-assisted surgery fit into this picture? Let's talk a little bit about the dynamics that are going on right now in the marketplace. Stay with me because this is a really important point I want to try to make here.

What the graph shows is this 60% of surgeries that are still done open, and you can see that in and of itself is an $8 billion market growing at low single digits. Below that, you see minimally invasive surgery, 30%-35%, a $9 billion market growing mid-single digits, high single digits. Both of those will be drawn into robotic-assisted surgery. So when I get to this 2%, you can start to see it. In fact, in audiences, I'll often be asked the question of, "Well, Bob, how do you feel about competing in this 2% space?" I'm like, "You're missing the point." This is about 98%. This is about 98% of the procedures that aren't being done today. That's about increasing market access, and that's something we do very well. We do that really, really well.

The reason we do it well is we understand the market. Let's look at the state of robotic-assisted surgery today. We know that this has been a market that's been in development for 20 years. I want you to pause and ask yourself why to a number of really simple questions. Why have 39,000 surgeons been trained in robotic-assisted surgery, and yet a fraction of those actually perform it? Why, with 5,000 systems installed around the world, are they used on average less than one time a day? Why do we only have 2% of the procedures that could be done via robotic-assisted surgery being done? These are the fundamental questions. Now, we believe we have answers, and I think it's important to spend a minute to understand why the adoption and the utilization rates are too low. Right? Let's unpack this a little bit.

We believe, after spending time with thousands of surgeons and hundreds of hospital administrators, it comes down to two issues. It comes down to cost and utilization. The actual answers might surprise you a little bit because on the surface, you think, well, that sounds obvious, but it's not. Let's look at each one of these individually. First, beginning with cost, you can read the quote. At our hospital, the biggest barrier to integration of robotics is cost. Well, they're expensive pieces of capital equipment. The consumables are expensive. They come with big service contracts. There's lots of other things involved. One of our misperceptions early on was that, well, this is a capital cost problem. It's not really a capital cost problem. Hospitals are more than willing to play a million-dollar plus price tag for a piece of capital equipment.

What they struggle with is the cost per procedure. This is a really important point because the comparator is how much on a per procedure basis does robotic-assisted surgery versus LAP, right? Laparoscopic surgery. This becomes the barrier. Another insight that you might miss at first, I know I did, was the cost per procedure does not just get in the way when you've got an installed robot and it's sitting idle and you're only using it one time a day. The cost per procedure is actually a barrier to acquisition. Because when you think about what you're going to get out of this on a cost per procedure, you struggle. You struggle with the economics today.

This limiting fact, I'm going to come back to this, and Megan, we're going to talk specifically how we address this, but this cost per procedure is really important that we understand. Let's go to the second barrier. This one, again, is a simple quote, but it's an incredibly powerful one. "Robots tie up the room." What is that meant? As I mentioned, the average use of the 5,000 robots around the world is less than one times per day. These robots are big. They're heavy. There's a lot involved, there's just natural resistance. Once you have an OR dedicated to a robot, it's unlikely that you're going to use that OR for other things. There are places around the world, in fact, I look at Hartford Hospital right here that runs a tremendous robotics program.

They've got very high utilization of their system. The numbers don't lie. The fact is that when you have a robot, current manifestation of a robot, you have a tendency to tie up your operating room. That in and of itself creates a great burden because I certainly cannot do an open procedure or a lap procedure working around the robot. It gets very difficult. I want you to hang on to that. You get these two dynamics together of cost per procedure, and then you've got low utilization, and so you get what you get in terms of today's barriers. Now if you keep those in your mind, as I ask Megan to come up, we'll talk about how we address those fundamental barriers. All right, Megan, come on up.

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

Thanks, Bob. Good afternoon, everybody here in the room in Hartford and those of you that are joining us online. I'm going to step out a little from the podium. I'm a little worried you guys can't see me behind here. I'll do a little bit of a walk and talk. I wanted to start off with kind of going back to the beginning of this program. From the first day when we started focusing on surgical robotics, the team was working really closely with surgeons, with hospital administrators, with economic decision makers to understand how are we going to overcome those barriers that Bob has walked us through today. Through that process, there were a lot of iterations of form factor, of architecture, lots of different prototypes, including, but not limited to, we were playing around with integrated robotic systems into OR beds.

We had multi-cart systems. We had single cart systems. We had boom mounted systems coming from overhead. We even had, not making this up, suction cup mounted systems to OR floors, faux OR floors, all of these different things that we've been exploring and constantly getting feedback from our surgeons and hospital administrators of does this move the needle? This move the needle meaning does this system and architecture overcome those specific barriers that are going to allow you to either use robotics more often if you have it today, or overcome a barrier, both perceived and real, of why you haven't purchased a robotic system today and started using it. With all of that's been going on for now seven years.

Again, lots of iterations of that, and I can't be more excited than to share with you for the first time, except for those that snuck a peek at the 8K, of what our system looks like. With that, we'll take an inside look into our Medtronic robotic assisted surgery system. What you see here on the screen are three of the components, and we'll talk through each one of these. There's a fourth component that we'll also come back to that I'm guessing people would like to hear about, which is the surgical end effectors, the robotic end effectors. We'll talk about those as well. Before I go into each one of these components individually, I want to kind of take a pause here, and at first glance, there's something that pops out right away, right? It's modular.

It's kind of the thing that's kind of the theme. You'll hear us talk about this a lot today. We refer to that modularity, we call it a keystone feature. It's a feature that underlies a lot of the elements and the other features that we'll talk to, and really helps us with overcoming those barriers of both cost and utilization. Hang on to that idea of modularity, and forgive me, you will hear me say it a lot because it is an important component. With that, we'll jump into the first subsystem that we have here over on the left side. This is our surgical tower. I think that many of you are probably familiar with surgical or laparoscopic towers. This one has a couple features that are important, and before I get into those, just to sort of orient what we're talking about here.

This surgical tower comes with a visualization system, an FT10 generator from Medtronic, and then we also have computing power. There are processors that are housed in this tower, and you see a monitor at the top that's mainly used by the OR staff for different features. There's a user interface and ability to view in the endoscope through that monitor. You have this tower here, and you'll note that the first feature that we talk about is that it's universal. What do we mean by universal tower? What this means is you can use this tower in a robotic case, you can use it in a laparoscopic case, and it actually has features that are relevant for open surgery as well. Take the visualization system. We've partnered with Storz, as many of you know, and I'm sure have read about.

We have a STORZ 3D visualization system that's housed in this tower. That STORZ system can be used in 2D mode, which is typical during laparoscopic procedures, and it can be used in 3D mode, more typical, and has advantages in robotic assisted surgery. The other piece that makes this a universal component of the tower is the endoscope. The endoscope that comes with your STORZ visualization system is a standard length. Sometimes you think, well, standard, that doesn't sound great. That sounds standard. Standard is actually really important because it means that we have designed a robotic system that uses a standard endoscope. That means you can also take it off of a robotic system. You can use it manually and handheld in a laparoscopic system. I think this probably comes to mind as to why that can be important.

We're going to come back to it later, this idea of the universal nature of the TAVR. The second piece I'll come back to is that FT10 generator. This is the Medtronic generator, and this is designed to power devices in robotic-assisted surgery that emit energy. It is also designed to power laparoscopic devices. It is also designed to power open surgery devices. All of those things that emit energy, which are used in some flavor or variety in almost all surgical procedures that are performed. That's some of that universal nature. We'll talk about that more in the other subsystems. The other piece that you'll see here as a common theme is upgradeability, and we talk about field upgradeable systems and components. That field means the hospital. We can change and upgrade the system in the OR or in the hospital.

For the tower specifically, as we have new visualization systems coming from STORZ and our partnerships with them, we can easily change out that visualization system there in the operating room in the OR. Similarly, with our generator technology, as that continues to advance, we'll be able to upgrade that component. Lastly, we have a pipeline of software applications and features that we're building now and will continue to roll out, and we can upgrade and upload those new software features into the tower, into the overall system there within the hospital. That idea of upgradeability, we have taken that through all of the subsystems that you'll see here.

An important part of where that came from was spending a lot of time with hospital administrators and economic buyers in particular, and saying, "What are the things that you worry about not only with robotics, but other large pieces of capital equipment, other things like electronic medical records? What's the stuff that's heavy on your mind?" One of the top things that continued to come back was, "I'm really afraid that I'm investing millions of dollars in technology that's going to be obsolete in a year.

I'm seeing that happen in my hospital, and I'm not able to satisfy the needs of my surgeons and of my patients and keep up with the pace of innovation." We took that in, and we said, how are we going to build a system that we can then commit to being able to upgrade in the field or the hospital when technology advances, so you're not required to replace your entire system, thereby increasing the return on investment in robotics for our customers? We'll take that now next into the surgeon console. One thing that'll pop out right away when you look at this console, it's open. It's an open design. Similar to what I shared of that form factor of how are we going to mount the carts, what is that going to look like?

We have had so many iterations and prototypes around this console. In particular, we started out with the idea that, hey, this thing needs to be something that is more of a closed design, something with a binocular viewing, periscope view. How do we make sure it's immersive? All of those types of things, we've had all versions of those prototypes and a lot of things in between, frankly. The feedback that we got from our customers was, "Hey, if I'm going to move into robotics, if I'm going to increase my use or I'm going to start to use for the first time, it's really important to me that I stay connected to the OR." What do you mean about connected? There's a literal, I am connected to the things that are going on in the room. There's a psychological, and there's a component of communication.

What we heard is, "I as a surgeon, it's very important to me to not be isolated from my patient and what's going on there. It's very important for me to feel connected to the overall staff and the activities going on in the environment." If you dig a little deeper, that comes up around specifically about communication. I have to be able to communicate and hear clearly and quickly and be a part of that conversation that's going on in the operating room. That was one of the things that led us to have this open console, open design. The other piece is one that's around ergonomics. Similar questions and probing on what do you need, what's keeping you from adopting robotics today? This system is designed with ergonomics specific to the back and the neck in mind with surgeons.

We have a thing that I'm going to fully admit this is a bit of a marketing phrase that we use, that we've made up, that is around active resting. This is the idea that you can be in a comfortable and a relaxed state sitting at the surgeon console, and you can perform a procedure, and that active means that you're not confined into one position the entire time you're doing a surgery. You're back, you can move around, you can communicate, you can turn, et cetera. This system is designed with that active resting in mind. Those are a couple of those key features that you'll see there. The other that we mentioned in the tower is the 3D HD visualization system. I mentioned the word immersive before.

That's something that we've been focused on, of how do we give that feel, first making sure that it is important and that it's of value. We spent a lot of time with the choice of the monitor that you see here on the console and the mode of which you see 3D. We have 3D glasses that you don't see here, but those are the ways that you use this monitor and see in 3D. By having both the size, the quality, the definition, and those glasses create that immersive feeling that we've heard from surgeons that they appreciate.

By having this, again, as an open console, we get back to that idea of upgradeability. I don't know about you all, but I don't see many categories that are moving as quickly as visualization and monitor technology, whether that be in consumer electronics or in the healthcare field. By having the system this way, as that technology continues to advance, we can go in, we can literally unscrew, it's a little harder than that, but this monitor, and replace this with an advanced technology as it comes out. Again, protecting the return on investment and keeping our surgeons in line with technology as it advances. Okay. Now we'll jump, I'm going to capture kind of three different things all at once. I think about these three last subsystems as coming together as the element that makes up the patient-facing aspect of this robotic system.

You'll see here the robotic arm itself, the robotic cart, and robotic end effectors. These are additional robotic arm carts. They are the same size as this one here in real life. We've got four of these carts. Starting with the cart, you'll see Designed for Mobility. You probably say, "Well, it's got wheels." Okay. It's got wheels, it's designed for mobility. There are more pieces that come into that. Part of it is the footprint, part of the size, part of it is the ease and how you move this cart around. The requirements around mobility for us really come down to two different scenarios or use cases. One is mobility within an OR, within a single room. We'll talk about that. It's the mobility between ORs, moving it around a hospital from operating room to operating room.

The reason that this mobility within an OR is important can come to life when we talk about going back to this universal nature of the tower and some of the other components that we'll talk about. You can imagine a surgeon has just completed a Medtronic robotic-assisted surgery procedure. Patient has been closed, wheeled out, and that system is now being undraped, and you want to do another procedure. Say the next on the docket, on the list, is a laparoscopic procedure. You can take these robotic carts, you can push them out of the way. You can leave your universal tower there for use in the laparoscopic case, and you can start your second procedure, whether it be a laparoscopic or an open procedure. That's the idea of mobility in the OR.

Just think of it as you can push it out of the way, and keep going with the next procedures. The idea of mobility between ORs comes in with something that can enable back-to-back robotic procedures. Imagine a hospital that invests in one system that you see here with four robotic arm carts. A OR number 1 set up and prepped. OR number 2 is also set up and prepped. You have your system in OR 1. Surgeon comes in, does the robotic-assisted surgery procedure, walks out, takes a break. The OR staff dismantles and undrapes that robotic system, and then moves it into the already clean, sterile, and prepped OR number 2. The surgeon comes in, commences the next case.

When we think about that utilization rate that Bob shared with us of fewer than one procedures done today robotically, that's one of the things that can help with the patient workflow, is that ease of going from one OR into the next. Kind of adding on to that sort of imagine a world and the use cases of this, we'll get into the flexible use. Flexibility and use of this system comes in in a couple ways. One of those is that you'll see these are four independent carts. We've designed the system so that you can use one arm, two arm, three arm, four arm in a procedure. For those that are not being used, we have also designed the system so that these components are swappable, interchangeable.

What that means is that I'm in a procedure as a surgeon, and I've decided to use two arms or three arms in a procedure. That one or two that's left that I'm not using, I can wheel that over to another OR, pair that with a second monitor and console, and start another procedure. This idea of the flexible use with this you can swap and you can share components becomes really, really impactful for those hospitals that are looking to either expand their existing robotic practice or they say, "I really want to start a robotic practice. I need to and want to outfit multiple ORs to be able to do robotics." There's some cost constraint with doing that with solutions that exist today.

With this, you can imagine that a hospital can buy a console, which again, can be used in open lap, and robotics. They can buy the laparoscopic tower, and they can move that into every single one of their ORs, and they can buy a fleet of robotic arms that then can be shared across those operating rooms. Those are some of the elements of the flexibility of use for the system. We'll switch over to robotic end effectors. Before we get to Q&A, I'm going to anticipate a question because I get it all the time, and that question is, you just take Medtronic instruments, and you duct tape them to the end of a robot, right? That's how that works. No.

What we do with our robotic end effectors is we leverage the know-how, we leverage the IP, and we leverage that 60 years of history in surgical instrumentation, and then we have designed specific wristed robotic end effectors that take that know-how and IP into consideration, but also says, "We want to design something that's taking advantage of the fact that you now have a robot. You now have a highly powered computer within the OR. How do we make those instruments maximize the benefit of being robotic while leveraging the great about Medtronic laparoscopic instruments?" We'll get a chance to see some of these wristed instruments later today when we have a procedure. The other piece that I'll pause on here, kind of going back to that idea of universal.

The one place, and we spend a lot of time thinking of, are there those situations where we want to just take existing Medtronic instrumentation and put it on a robot? There is. That's the stapling reloads that we talked about before. The exact same Medtronic stapling reloads, we talked about Tri-Staple, et cetera, that you use in laparoscopic procedures are the ones that you'll use in robotic procedures. That has a lot of benefits. You could probably think about some of those already. One is that surgeons know, trust, use stapling reloads from Medtronic today. They understand how they work, where they work, when to use which kind, so we don't have to have a learning curve associated with something different or new. The second piece is really it's an inventory management situation.

You now no longer will have to carry both your laparoscopic stapling reloads and robotic stapling reloads. You go to the shelf, you take one off, and they're interchangeable between the types of cases. That, I know that was a lot, but hopefully helpful on walking through some of the features associated with our system. As I mentioned, we've said a couple times, we work so closely with surgeons day in, day out, but we also want to make sure that we're not missing something. We do a lot of pressure testing of our assumptions, and we go back and back and back to the market. Do we still have this right? The market is changing dynamically, both from a technology standpoint as well as needs. We do a lot of market research around that.

I wanted to share one of those, that's one of the more recent. This was earlier this year in spring of 2019. We talk about our value proposition, and how do we make sure that that value proposition resonates not only with the surgeons that we work with every day to design the system, but to the larger segments of the market that we're going to target when we launch. There's two groups when we think about who we're targeting with this system. On one hand, you've got folks who have already bought a robot, they use a robot, but they underuse it. There are barriers to increased use.

You got those folks over here, you got these folks over here that over the past 20 years, for whatever reason, we look to find out why, they have not purchased or not adopted robotics. Users that are underused, non-users. Those two groups. We'll talk about some of the numbers there. What this research is telling you, we did quantitative and qualitative around, let me describe to you our robotic system. A lot of the ways that I just described to you guys of walking through those features, let's talk about the implied benefits, they wrap it all together with a pricing statement. The pricing statement that we have here at the bottom of the screen is, what if we could bring this concept, this product from Medtronic at the per-use cost of lap?

Benefits of robotics at the cost of lap. That's the way that we package this all together. Then we go out, and for this particular example, this was 250 surgeons and hospital administrators, both current users of robotics, non-users of robotics in both the United States and Europe. This is this study, and expose them to this value proposition at this price point, per-use price point parity to laparoscopic. We ask them a ton of questions. Do you believe it, right? Do you believe that Medtronic can bring it to the market? Et cetera. Two of the questions that tend to be the most salient in terms of telling us what is the appetite for this product, how well is it going to do when we launch it, are on things that I refer to as product appeal.

Product appeal, many of you may be familiar with this is it right for me? Does it meet my specific needs? I like it. Its appeal. The second is purchase intent. Are you going to buy it? It's great that you like it. Are you actually going to buy it? We take a look at those two factors from this particular research. What we find are very high numbers. As Bob had mentioned before, I have a career that spans consumer products and disposable surgical devices, medical devices that are made for consumers, and also large capital in the imaging space as well as robotics space. Across all of those categories of trade, this is a pretty similar methodology that you look at for launching a product. These are high numbers.

Particularly when you look at the purchase intent that we'll talk about for things that are a high price tag, think, again, consumer electronics, luxury goods, cars, medical device equipment. These are significant and very exciting numbers. On the value proposition, is it appealing? Meaning, does it resonate with me? Do I like it? What this will tell you is that 83% of people who own or use a robot that were surveyed said it's appealing or it's very appealing. That's that 83%. We call it a top two box, appealing or very appealing.

If you look at those who have, again, over 20 years, nothing's made them move the needle to go into robotics to purchase and to use, of those, over 75% of those folks said, "Yeah, I find this concept and this product from Medtronic to be appealing." Again, we take it down to, that's great. Glad that you like it. Now we go into purchase intent. You'll see this is worded purposely around likelihood to advocate for purchase. I'm sure as many of you know and have experienced, if you ask a surgeon, will you buy it, that's a little bit of a tricky question. You'll get some noise in the answers around that. It's not that surgeons don't care what something costs, aren't aware. It's none of that. It's that they don't literally write the check.

They're not the people who are purchasing. What they are doing, and is almost more important and impactful, is they're fighting for your product. We change that to the currency that surgeons trade in, which is their influence, their brand equity, their voice, their time. This question of how likely are you to advocate for the purchase of the Medtronic robotic-assisted surgery platform, as we just described it. What we see is those that currently own and use a robot, 68%. 68% of people said, "I am likely or very likely to advocate for the purchase of that system." If you take a look down in those new users who have not yet entered the category, you've got almost 65% of them say, "Yeah, I'm likely or very likely to advocate or fight for the purchase of that product." Some of the quantitative research.

The last thing before I hand it over to Bob, I thought I would share a couple of the verbatims. Like I mentioned, we do really countless hours of qualitative work. These look like one-on-one interviews, focus groups, kind of you name it. We do a lot of talking. With those customers that we talk to, there's a couple of these quotes I thought that you can read all of them, obviously, but worth kind of talking about more. One of them was this one in the top in the middle. "You don't want to be anchored to an operating room. Real estate is expensive." The first time that I heard this phrase of real estate is expensive, it was pretty compelling.

I'm kind of digging in, listening more, and this is actually becoming more and more prevalent, particularly outside of the United States, where you've got the advent of more technology, and particularly large capital equipment, at the same time that you have hospitals trying to do more with less. You've got consolidation of hospitals. All these things are happening. It's getting tougher and tougher to be able to dedicate space within a hospital to a single procedure, a single technology, or a single specialty. That keeps coming to fruition. The other one that I would say is this hospital executive quote, on the top right up there. "Per procedure costs have always been an issue.

This is important as earlier robots have not been able to achieve this. That this here again, is that value proposition of offering the benefits of robotics at an equivalent per-use cost to that of lap. The last one that I'll hit on here is the big blue one that you see here on the right. That is built-in compatibility with instrument stapling and vessel sealing technologies surgeons use now, and you create a natural step forward instead of a total reset. This idea of how do you advance technology, how do you solve meaningful problems without being disruptive in a negative way that's going to cause a lot of behavior changes or slow your adoption curve, comes to light a bit in that quote. With that, I'm going to ask Bob to come back up, and thank you guys for your time.

Bob White
President of MITG Business, Medtronic

Thank you, Megan. Standing, as always.

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

Thank you. Thank you.

Bob White
President of MITG Business, Medtronic

You feel the excitement in where we're at on the journey. Let me talk and give you some details about the so therefore what. What does this all mean as we think about where we are? I'll do a couple of charts I think that will be very helpful for you, that look at the launch sequence, our financial impact, and then as I mentioned, I'll come back and talk about the pipeline. Let's look at this slide right here. What you see on the slide is, as we had previously committed, we will begin our initial launch in the second half of this fiscal year. Again, a reminder, all of you know this, but that our fiscal year actually ends in April, right? When you think fiscal years, not calendar years here. This is really important, right?

This is important because this allows us to begin to gather clinical data. We're really excited about this. I'm sure it will come up. I'm not going to disclose where specifically we're going in the world with that, but we're really excited about that. Another important progress point, if you will, is when do we anticipate filing for CE mark submission? We anticipate this in Q1 of our fiscal year 2021. That's the anticipation of that. Another very important milestone is the filing for IDE. All of you in this room who cover medical devices will realize the significance of an IDE. Underneath that IDE in the U.S. allows us to begin to place systems, allows us to begin to train surgeons, allows us to begin to collect even clinical data, of course. Those dates are important.

We like to think that we have some control over those, and the team is working very hard on those. The two dates to the right-hand side of the chart, of course, is a little bit out of our control because it depends on the regulatory authorities and agencies around the world. We've had multiple conversations with competent authorities around the world, and we plan, if you will, for a CE mark approval to be in the second half of FY 2021. Truly our rough best estimate for a U.S. approval would be 24 months from today. That's about the range. Of course, I'd ask you again to think about those are very active discussions, but that's our timing as we think about it today. Those are set some pretty clear points of demarcation, if you will, and we're very excited about that.

Now, once we have an approved, safe, effective device that's approved for market and sale, what do I think it's going to mean in terms of financial expression? This is the way I think about this. Really our first fiscal year, if you will, in FY 2021, anticipate the impact to be less than 50 basis points. That climbs to 100-150 basis points in FY 2022, 2-250 basis points in FY 2023. You can certainly see this will be a meaningful contributor to us. I wanted to give you that glimpse into how we think about that because I know it's on everybody's mind. Certainly, you can see we're very far along in our development of the system. You'll see a lot more and hear a lot more this afternoon.

That's a little bit of both the progress points as well as the financial impact. Let me, as I begin to wrap, go to the next slide here. This is an important slide. I draw your eyes to the left-hand side of the chart where I very purposely use words high-value capital, high-value consumables, and high touch. Oftentimes I get the question, well, you're going to give the robot away. Nothing could be further from the truth. We believe in the value of the platform. We absolutely believe in the value of the platform. We also know in the value of our end effectors and associated technology that Megan did such a nice job walking through. Then third, we absolutely are building a world-class customer touch organization to make this a customer experience that's on par with Medtronic, right?

Really important as we think through that. I lead you that because sometimes I hear a lot of different stories about that. To the right is really important. Megan did a nice job talking about the upgradeability of the system and the platform nature of the system. What I want to share with you is what you can expect is a cadence of launches, if you will. This isn't just about launching a single robot. Really, we think about these four technology vectors as being incredibly important in robotic-assisted surgery. First is, of course, the robotic system itself. You see the platform, and we talked about how we've built that intentionally to be upgraded. Instrumentation, very important. I took you through. We're the market leader in many of the surgical instrumentation categories.

Megan shared with you how the Tri-Staple reloads will fit right off the shelf into the robot. This whole instrumentation is an area where you can continue to expect us to deliver on this incredible 60 years of innovation, right? Third and fourth are very important. This speaks to data and analytics and visualization. While I won't go into the pipeline that we've got for each of these two areas, we think these are game changers, right? Ultimately, if you think about what a robot does, it's better eyes, it's better hands, and maybe a little even better intelligence for the surgeon, right? If you can augment those through data and analytics, both in the procedure, before the procedure, after the procedure, becomes very compelling. Visualization, we just think we're getting started on that.

You can expect to see as you think about our cadence of where we're going, that these four vectors will continue to play out over time. It gives you a little sense of the future. Let me bring this all full circle for you this afternoon. I said we are going to talk about really three things, where we've been, where we are today, and where we're going. Hopefully, as I conclude this management presentation, you reflect on where we've been is incredibly relevant to entering robotic-assisted surgery market, and we feel really good about our history of innovation. Where we are today, I'm going to draw you back to that 2% number. Only 2% of eligible procedures are done via robotic-assisted surgery today.

I want you to think about there's 98% out there that needs to be done via robotic-assisted surgery, but not today because of the cost and utilization burdens that we talked about. We described hopefully our solution really well. You're going to get a lot more on that today. You're going to hear from the voice of our surgeons. Megan and I will be up, and we'll take questions and answers as well, so you get a real sense of why we did what we did with our solution. Hopefully the information I gave you relative to the global launch cadence was helpful and provided you with real actionable information. Hopefully, that was great. We're going to have a lot more time together today, but that kind of brings it all together, where we were, where we are, and where we're going. Okay?

With that, I'd actually like to transition to something that I find really cool. What we're going to do in a minute is we're going to live feed into the operating room, where again, you're going to be witnessing a cadaveric procedure. Before we do that, I think it's important that you get a sense of how the system actually sets up. The reason we want to do the live setup and draping is, one, of course, so you'll get to see the robotic arms without the drapes on them, so you'll get to see them. You'll also get to see the incredible orchestration, a ballet if you will, of the modularity of the system and the flexibility of how it comes into be. I think you'll really appreciate the elegance, if you will, of how the system was designed.

We've got Tracy Accardi live in the operating room. If the technology, not our surgical technology, if the audio technology works, we're going to pipe Tracy in right now and hopefully have her pick up the dialogue. Tracy, are you there?

Tracy Accardi
VP of Research and Development of Surgical Robotics, Medtronic

I am. Thank you, Bob. Welcome to the OR. As a reminder, what we're going to show you today are devices that are in development, and this is testing as part of our development program. In the next several minutes, I'm going to describe some of the things that you see in the OR while we set up the robotic system before we begin the surgical procedure. To begin, behind me you see three robot arms already draped and ready for setup. This fourth arm has not yet been draped, I will use this as an opportunity to show you some of the aspects of the arm cart that you'll see in use today. Fundamental to how the robot arm works is the concept that we operate with a mechanical remote center of motion. This remote center of motion is what enables minimally invasive surgery.

As you can see by the movement of the arm, when the system is in teleoperation or remote control mode, the system is mechanically constrained to rotate around a point in space. We set that point in space up so that it's aligned in the abdominal wall, high up in the abdominal wall, and aligned to the previously placed access ports. The rest of the mechanism that you see behind the active robot arm is here to allow for setup of our system and positioning of our arm carts around the bed. As Kevin moves the arm around, you can see that we really see an opportunity to do all of the height adjustment and locationing. Before we move to the next step, I'd like to take a moment to demonstrate a few additional aspects that aren't as obvious once we drape the arm.

Before I do that, I'd like to point out that because we are doing things slightly out of the normal setup process so that we can show you how things function, you might see some lights flash. These user signals are from computers within the robot arms and are intended to guide proper setup of our system. The first thing I'd like to highlight is the orange strip along the length of the arm. This sensor will stop the system if someone presses on it anywhere along its length. Next, we'd like to show you our laser registration system. Registration ensures that all of the robot arms share a common reference point. Registering all the arms to the bed ensures that the arms know where they are relative to the bed and to each other in order to enable teleoperation.

Our laser guide, combined with intelligence in the arm, allows the arms to move in the right direction once the system is in teleoperation. In order to set the laser, you simply turn the knob and line up the light parallel to the bed and press the button. On the back of the arm, you'll also see another interface that's designed to provide more information to the bedside staff. This small screen is used to communicate and distribute information where it's needed. For example, arm identification information, and then during setup, positioning information obtained from the computers in the arm. Here at the distal end of the arm, you can see the mechanism that we use to connect to our robot to the access port. We're designing the system to use both titanium reusable ports and plastic disposable ports. The access port clicks into place by closing the latch.

As we're doing this, you may have again noticed some flashing lights at the base of the arm indicating a warning. This is because in typical use, we would have installed the sterile drape on this arm before connecting the access port. At this point, I'm going to step away from the bed and allow my surgical assistant to put the sterile drape on our fourth arm. While Kevin's doing that, I'll point out a couple of other features in the room. Behind the system, you can see our tower, as Megan described before. You can see that the tower contains our FT10 electrosurgical generator, Medtronic's same electrosurgical generator used in laparoscopic surgery. In addition to the FT10, you can see the 3D HD visualization system.

This vision system allows us to capture and display both 2D and 3D images, and is also a standard laparoscopic version of a vision system that we've adapted for our robotic platform. On top of the tower, you see a monitor. This monitor will be used to display both system information as well as 2D endoscope views to the OR staff. To my right, you see the surgeon console. You can see that it is an open [audio distortion] be driving our system using interface devices that contain multiple control inputs. At the surgeon's feet, you see foot pedals dedicated to controlling the energy application, clutching, and moving the camera. The final observation for you to make in the room is that our system has separate arm carts, as Megan described, that can be set up in different configurations. The procedure you'll see today will use four arms.

However, the system setup would be the same with two or three arms if you didn't need all four. Kevin has completed the draping process, and as we look at our cadaveric test subject, you'll see that the other three robotic arms are already in position around the bed, and that we've already placed ports into the cadaver. The positions of both robotic arms and ports are deliberate and were planned based on our intended procedure. As we've developed this system, we've put a lot of effort into determining the positioning of our robot arms with respect to the patient. We designed the system keeping in mind both the range of motions the tool had inside the patient, as well as the use of space outside the patient.

Based on the intended procedure, we will be providing guidance in our instructions for using the system, as well as in the training programs that will teach our clinicians how to best use our system. All of our arms are designed so that they're interchangeable, meaning any instrument can be attached to any arm. For example, intraoperatively, you may decide that you want to move the camera to a different port for better visibility. This is accomplished by detaching and moving the camera. Each arm automatically determines which tool or scope is attached and makes the necessary adjustments. You may see this happen several times during the procedure today. As Kevin begins the docking, he will be connecting the robot to the access ports.

This final step, as I said, called docking, secures the robot to each of the access ports and allows the insertion of the instruments into the cadaver.

With that, we're ready to send control back to Ryan in the auditorium while we make final preparations to start the cadaver development surgery here in the OR. Thank you.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

For the next part of the program, you're going to hear from a panel of surgeons who describe their opinions about robotic-assisted surgery with devices currently on the market, and their experience with the Medtronic robotic-assisted surgical system. Each of the surgeons on this panel has been and continues to be a compensated consultant for Medtronic. Since the Medtronic system is investigational and still in development, do not infer safety, effectiveness, performance, or suitability for use in any specific surgical application. The device does not have regulatory approval in the U.S. or any other country and is not available for sale or clinical use. The safety and effectiveness of Medtronic's robotically assisted surgical device has not been established. It should also be noted that the statements made by the panel are for investor information only and not intended for promotion or sales to healthcare practitioners.

With that, I'd like to welcome up to the stage Carla Peron. Carla is our Medtronic VP of Medical Affairs for our Surgical Innovations division. Carla.

Carla Peron
VP of Medical Affairs, Medtronic

Thanks, Ryan. Hello, welcome to the surgeon panel part of our agenda today. We've heard Bob talking a little bit about the robotic market, Megan talking about our solution, and now it's time for us to bring a little bit about the clinical voice to this discussion. In order to do that, I would like to invite my colleagues to the stage. Excellent. Thank you. Thank you all for being here. We really appreciate you sharing your perspective on our system and our development. I'd like to start with some introductions. Just, Bob introduced me myself. I'm a gynecologist by training, minimally invasive surgeon, joined Medtronic five years ago. Most recently joined the robotic team in order to support the clinical strategy development, to help us to get to market. I'm here with a couple of colleagues from different specialties.

I'd like to invite you all to introduce yourselves. Please share your name, your specialty, hospital affiliation, your experience as robotic surgeons, and also your experience a little bit with the Medtronic platform under development.

Daniel Portnoy
General Surgeon, Duke University

Thanks, Carla. It's a pleasure to be here. My name is Daniel Portnoy. I'm a general surgeon at Duke University. I do a specialization in both minimally invasive general surgery as well as bariatric surgery. I've been involved in using Medtronic products through basically my entire career and have certainly come to depend on them over the years, and partnership with surgeons and industry is critical. I first got involved with robotics back in about 2005, and in 2014, got involved with the Medtronic robotic team and have been working with them through development stages from that time on. I've been able to work with the FDA and some of their robot-assisted surgical device team as well, with some of the rules and regulatory requirements around robotics, and have worked with Medtronic with some of their advisory board in education around bariatrics, and appreciate being here today.

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

My name is Yuman Fong. I'm the chair of surgery at the City of Hope Medical Center, and it's a cancer center in Los Angeles. I did my first robotic liver operation back in 2004, and so I've been in this field a long time. I oversee a department of surgery that's very traditional, that has everything from neural surgery all the way down to podiatry. I oversee a surgical department that has done over 13,000 robotic operations. I edit the SAGES Atlas in robotic surgery, where step-by-step instructions for how to go do 27 different operations are illustrated. I think about education in a very big way. I've been working with Medtronic on this robot since 2014.

I also participated recently in a series of workshops to talk about how to train surgeons in robotic surgery, as well as retrain surgeons in different robots that are going to be available on the market.

Rubén Olivares
Urologist, Clinica Santa Maria

Hello, everybody. My name is Rubén Olivares. I come from Chile, from Santiago. I work as a director of robotics in Clínica Santa María, a private hospital there. I have been performing robotic surgery since 2011, and I do about 200, 250 cases per year. I have been involved in the development of Medtronic's robotic program since 2016, and I also have supported several validation activities in the dry lab.

Carla Peron
VP of Medical Affairs, Medtronic

Excellent. Thanks for introducing yourselves. As you can see, I'm joined here by an esteemed panel of surgeons, from different specialties, different regions. We'll be getting into a little more granularity about, in your opinion, what are the benefits that robotic-assisted surgery brings to your specific specialties? What are the unmet needs that exist today in the market?

Daniel Portnoy
General Surgeon, Duke University

Sure. Well, in my field of general surgery and bariatrics, we get to reap the benefits that we know a lot of about robotics. The 3D visualization is certainly superior to that which we get with the standard optics. The wristed instrument control and the precision in our movements is critical for the activities that we're sort of performing. Maybe even just bringing it very specific to me, in bariatric surgery, we're operating on very heavy patients, and they have very thick, rigid abdominal walls, and you feel like you're almost in a wrestling match that you've lost at the end of the day because you're fighting against these very difficult abdominal walls.

Just the ergonomics of being at the robot make that such an easier experience on the surgeon, and allows us to stay fresh and be able to do a good operation all day long because we're sort of battling against those specific patient characteristics to our space. As far as an unmet need goes, I think the biggest that I think I've faced in my career is just sort of access to the robot. At Duke, we're a big university center. We have, I think it's somewhere between eight and 10 robots right now, but the number of surgeons interested in using those robots far outnumber the access to the robots. So we kind of get in this competition of trying to fight for robot time, and the system, as a result, tries to develop rules around, hey, giving everybody access. That gets very challenging.

What these rules end up doing, because it's sort of this limited resource, is makes it such that no one gets to use it to the full degree of efficiency that we'd like to, that we just can't get on it and use it as regularly as we'd like. As a result of these rules and these systems, they don't get used as efficiently as we like. I don't think that we've just developed this sort of institutional efficiency that we should get. This limited access, I think, is driven by cost, and I was very happy to hear in the presentation today that there seems to be a strong effort to rein in that cost.

Carla Peron
VP of Medical Affairs, Medtronic

[audio distortion]

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

I do mainly liver and pancreatic surgery, and as you know, traditional liver and pancreatic surgery, it's a giant incision. It's a lot of morbidity and recovery for the patients. The average patient stays in the hospital seven to 10 days, and it's six to eight weeks before they are back to normal. The idea of utilizing better visualization, more precise instrumentation, and ability to work around the corner really has transformed how we do liver surgery by an MIS fashion through robotics. I published a paper recently that says that robotic liver surgery can be outpatient surgery. Okay. Robotic liver surgery can be outpatient surgery. That's because half my patients now have it done robotically, and a third of those patients go home on the same day, and about 50% of the patients go home within 48 hours.

It changes how we take care of patients. When I now measure those patients' activities at home, I actually send them home with activities monitors because I want to know that they're doing okay, because these patients who usually are in the hospital for a week while we're watching them now are home. I actually need to know. It's not unusual for a patient to be back at 6,000 steps within a week. Okay. They are actually recovering. There's no doubt that if we could bring more robotic surgery to complex surgery, we'd probably do a lot better for our patients. Why don't more surgeons do that, okay. It's about the tools, okay. That's because cutting, sealing, and stapling matters. If you were playing surgical Jeopardy, right, and you say, "Stapling," you'd most likely say US Surgical.

If you say sealing, you probably say Covidien. Having a company like Medtronic enter the space, because U.S. Surgical and Covidien is Medtronic. Okay? Having a company like Medtronic enter the space is very exciting to me because, again, more tools means that greater penetrance and better care for our patients.

Rubén Olivares
Urologist, Clinica Santa Maria

I cannot agree more. As a urological surgeon, what can I say? Robotic-assisted surgery change and transform all the surgical field because the precise dissection, the better visualization, and the capability to movement and suturing, for example, in narrow spaces as the male pelvis. Now, I do more minimal invasive surgery using this technology, which is better for my patients, in terms of easier recovery, less blood loss, less complication as well. The problem, and maintain the link with the unmet needs, is that in Chile, like in many, many places and even in developing countries, the problem is the high cost.

What I mean is that having many well-trained surgeons face a big barrier that reduce the access for the patient to the technology is the high cost per procedure that we face today that get away the innovation and the technology for the caring of our patients.

Carla Peron
VP of Medical Affairs, Medtronic

Yeah. Definitely couldn't agree more. I think in the gynecological space, the ability of working deep in the pelvis and suturing, it's completely a differentiator overall. The robotic plays a huge role in that arena. Now that we understand a little more about how the robotic system itself can play an important role into the expansion of minimally invasive surgery. All of you had an opportunity to have some level of experience with the technology that Medtronic is developing through labs, advisory boards, pre-clinical testing. I would love to hear your initial opinion about what you have seen so far.

Daniel Portnoy
General Surgeon, Duke University

Sure. Well, there's been a number of features that I've liked. I think one of the biggest factors for me is that as a surgeon, when we're doing procedures, we have options. A lot of what I do with bariatric surgery is sewing one organ to another. As a surgeon, I like to believe that I could just sew that up better than any device or any instrumentation could perhaps do that for me. What we've found over the years is that stapling, most of the time, does that better. That's been hard for us as surgeons to fully accept is that we don't do it as well as a device. When we find a device that does it better, we're putting a lot of trust into that device. We, as surgeons, kind of become creatures of habit.

Once we get something that's working, we don't really want to veer off of that. We develop this trust in our instrumentation. Being able to see a platform that's going to come forward, that's going to have the access to the tools that I've been used to using for the past 10, 15 years of my career, is really critical to me to just allow me to kind of fully embrace the trust that I'm used to, and just seems like a natural evolution into the next phase. When we get specific to the device itself, I saw mention of the concept of open console. To me, that's important.

As the surgeon, early on in my surgical career, I was kind of told, "You've got to be the captain of the ship," that you've got to own that operation, but you have to kind of control everything else going on in the room. To me, being able to kind of visualize the entire space and have access with the entire team, yet still have this big screen that I can kind of like focus in on and really be right there in the operation, and transition back and forth between the two, is really key. The other thing that I found really interesting in this, is in many of my procedures, I don't necessarily need to use all four of the arms at any given time. Being a modular system, that fourth arm could be utilized in another room simultaneously at the same time.

We have several surgeons that use a physician assistant to do nothing but hold the laparoscopic camera during the case. They're working with an assistant surgeon, but they've also got a physician assistant doing that. Imagine you have a robotic arm that takes that over. That's a pretty big differentiator in my OR.

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

Again, I'm a chief of surgery in a cancer center. Again, cancer is the number 2 killer in America and of Americans. When you think about what launching a new robot means, again, for a lot of the engineers in the room, and I know there are a lot of engineers sitting in this room, the interest is a lot of times about the technology and about the advancement of technology. For the analysts in the room, and there's certainly lots of analysts in the room, it might be the market opportunity, the 98% of non-robotic surgery that might be converted to robotic surgery. Okay? For me, it's a little bit different. It comes back to the patient. That's because, again, no cancer patient, except in testicular cancer, is cured without surgery. Surgery is an essential part of cure for every solid tumor except for testicular cancer.

Right now, less than 20% of surgeries done in the U.S. for cancer is done by an MIS fashion, and less than 2% is done by robotic fashion. Therefore, trying to convert people to doing robotic MIS surgery is about the patient and about alleviating suffering and about better outcomes. That's really important to me. If you think about robotics, though, it really is just an instrument holder and actuator. What that instrument is at the end of the day counts. Having one of the world's best instrument makers enter the space means that we now have an opportunity for some of their tools to go on a very good platform to go forward, and so very important to me.

From an administrator standpoint, if we actually have instruments that are used for open surgery, laparoscopic surgery, for robotic surgery that are similar, then suddenly inventory becomes easier. Training of surgeons and maintenance of competence becomes easier. Those are all things that I care about as I sit at my desk signing all the papers, and so those things matter to me, too.

Rubén Olivares
Urologist, Clinica Santa Maria

As a urologist that do his practice out the United States, I say that because you have two wonderful urologists here in Hartford. I must say that I'm more than pleased to hear that Medtronic intends to address the high cost per procedure that I said earlier. When you asked me about what I really like about the platform, I would say, first, the modularity. For kidney surgery, you almost never use four arms. You always use three arms, so you don't need the four arms all the time. Second, the open console. I couldn't agree more of that because lets you maintain interaction with the rest of your team. Third, that you get away about the neck strain during a long day of surgeries. Four, the 3D glasses. The 3D glasses can bring democracy into the OR.

I mean, you have the same visualization between you and your residents for as well, so it can guide you where you are going during the surgery. Lastly, I think that the learning curve might be short because after a while, I felt very comfortable using the hand controllers and the pedals as well.

Carla Peron
VP of Medical Affairs, Medtronic

Excellent. Dr. Portnoy, maybe during our conversations, you also mentioned some elements about visualization. Would you like to comment something about that?

Daniel Portnoy
General Surgeon, Duke University

Sure. I think visualization is certainly a key element of what we do. Being able to move from the standard 2D visualization that we get with laparoscopy into 3D visualization just makes this all better and certainly overcomes a learning curve for new individuals coming into it, and is a critical element to it. It's such a huge factor of what we do, being able to see the tissue structure as well, et cetera. I think that being with a commercially available platform, the STORZ platform, we're also able to upgrade adequately as that makes over But also, transition sort of freely through various phases of the operation.

It may be that I might do a portion of the operation laparoscopically, but then flow into a portion of it that I want to be able to do robotically and transition back and forth between those smoothly, maintaining the same optics throughout.

Carla Peron
VP of Medical Affairs, Medtronic

Really appreciate that. Because we want to save some time for capturing questions from the audience, I'd like to ask a last question. There is some couple of different platforms entering the market in robotics right now. What do you believe that Medtronic can bring as value to this market right now?

Daniel Portnoy
General Surgeon, Duke University

Well, I've been at Duke for quite a while. I think I did my fellowship there in around 2005. Medtronic has been partnered through with Duke all that time. In fact, before I was even there, when Duke formed one of the original nine minimally invasive fellowship programs in the country, they partnered with Medtronic to do that. That partnership has long since been there. Through that, they helped me in part of my training. As I've progressed on in my career, we have together trained lots of surgeons, both in their sort of training years, but then surgeons that are sort of beyond training as well.

I think that being it a tool set that we use both in the open, the laparoscopic, and now the robotic platform, it just fills out the portfolio in a way that is natural and makes sense. It's progressing with where we're progressing in surgery. It's great to have our partner move into that phase of care with us.

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

I echo that. Here's Medtronic that's been in a lot of different surgical specialties, in a lot of surgical operations. It's not a niche company. I still remember coming up to New Haven to do the early U.S. surgical stapling courses and learning how to go through colorectal surgery differently now because we don't have to sew. I'm a little older than you are.

Rubén Olivares
Urologist, Clinica Santa Maria

I can't remember.

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

I still remember going out to Boulder when the ablation units were being rolled out to learn how to use them and work on the IN.PACT Admiral when it was just a concept and not an instrument. Again, it's about having a presence in many, many hospitals. It's about not just the tools, but it's the education, it's the support, it's the service. We know what to expect from Medtronic, I'm glad you're in the space. Having a whole portfolio of tools, going from open to laparoscopic to robotic now really allows us to go do inventory a lot better and to have options as to what the right option is for the patient. All of that comes together.

Carla Peron
VP of Medical Affairs, Medtronic

Excellent. Dr. Olivares?

Rubén Olivares
Urologist, Clinica Santa Maria

Thank you for the question. You guys can ask me anything about prostate cancer, but nothing about how to build a robot. What I mean is that it's a process that is very, very complex. The things that you have to put together is the confidence in the quality of the medical devices that you are developing or making new. In one statement, I think that the breadth of expertise in a large company as Medtronic is a cornerstone.

Carla Peron
VP of Medical Affairs, Medtronic

Excellent. Thanks for sharing that. With that, I would like to transition to Ryan to start getting some questions from the audience.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Great. Thanks, Carla. Thank you to the surgeons. We will now take questions from the audience for the surgeons. A couple of notes here before we get started. Please keep your questions specific to the surgeons' experience with Medtronic's robotic surgery system. I'd like to remind you that the system is still under development and not cleared or approved for use or sale in any market. The surgeons won't be able to comment on safety, effectiveness, performance, clinical outcomes, or clinical benefits of Medtronic's system. Importantly, they can't comment or make comparisons to currently available robotic surgery systems. I'll end with saying that any company or business-related questions, if you can just save those, we're going to have a management Q&A at the end of the day. Those would be more appropriate for that panel. With that, we'll go to the first question. Rick?

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

Yeah. We'll bring you a microphone.

Rubén Olivares
Urologist, Clinica Santa Maria

Who was that?

To Rick.

Rick Wise
Analyst, Stifel

Oh, you hit your hook. I can't hold mine. Rick Wise, Stifel. I think the question I'll start with is, if the physicians could comment. You all commented about the need for robotics, the potential for robotics, whether it's accuracy or comfort in partnering. You highlighted many of the benefits of partnering with Medtronic and Medtronic's involvement. I'd be curious, do you think that 2% robotic penetration, is there something unique about this moment that is going to see that minimally invasive portion of the market go down, the robotic penetration go up? Is there something about the system and its attributes that you think, "Oh, my God," looking ahead the next few years, we're going to be doing a lot more robotic procedures? Can you help us understand that perspective? Why now? What's changing? How does this system maybe drive that?

Daniel Portnoy
General Surgeon, Duke University

Well, I'm happy to tackle my perspective on that. I think that robotics is this budding technology that is kind of starting to interface with us in so many aspects of life. It's going to change our world in many sort of arenas, and I think that we're going to see that happen in surgery as well. Having a group that comes to the table that, as they've kind of alluded to in their discussions today, are going to start to help us overcome some of those barriers, cost being one of the biggest factors that sort of is a limiting item. Also bring out a tool set that is part of the portfolio with all the rest of the line of tools that they already have with a trusted company, I think is a recipe to allow this field to sort of really progress.

When you kind of partner that with a company that's been so involved in the education aspect of it. They've already got a well-oiled machine to bring out a new product, but have all the infrastructure behind to progress that into the future. If you take some of this cost structure and put that with it, I think we're going to see that advance the ball. What all of us are seeing is there's robotics today, but then there's the promise of all these things robotics brings in the future. As we start to get the cost down, man, we start to see those future concepts being reality.

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

Let me take it for a second. We always say robotics is just more MIS surgery, it's actually not true. It's better MIS surgery, okay? It's ergonomically better. It is better visualization. The most important part that's better is that we can do very skilled tasks in laparoscopic surgery routinely, robotically. If I'm operating on the liver and there's a hole in the vena cava, I am going to be asking for a stitch and not thinking about conversion as my first thing, okay? It's a different process. The trust in the technology, the ability to sew either-handed, okay? Either-handed, sew safely is very different than laparoscopic. Laparoscopic sewing is a highly skilled act that only really good surgeons can do on the heart and on the big blood vessels, okay? Whereas robotic surgery, average surgeons can sew very well, okay?

It's a different level, and converting from open to laparoscopic is actually hard. If you've been an open surgeon doing liver surgery all your life, and you're now 50 years old, to try to convert, it is a hard task. I'm convinced converting to robotic is a fairly straightforward task, and the learning curve is shorter for most operations, and that's borne out by data. Having more entries and more access to this technology throughout surgery is going to be good for the next generation of patients, okay? Having at least a goal of having it equivalent in price to laparoscopy, which is accepted in every major hospital in America, then transforms us. It's not about taking the 20% that's laparoscopic and converting them all to robotic.

That'll be fine, and I think that will happen over time as we train the next generations of surgeons because I just can't see that in one generation, 2 generations, the youngsters that are training through now is going to choose to go do the hard laparoscopic and not choose the easier robotic if we give them access, okay? It's also converting all those open cases that should be MIS to robotic. There are some cases that should never be MIS, okay? In surgery. I think for every specialty, we should have a list of those. For those that should be MIS, I'm just convinced we can convert them to robotic much easier and have higher levels of competency if we train people right. I think this is a watershed moment that's because, again, the company that exists is very good, okay?

The product is very good, okay? I use it every day, okay? Having more people into the market and having more tools, having more options, it's got to be better for all of us. I actually see this as a watershed moment.

Rubén Olivares
Urologist, Clinica Santa Maria

I think that two concept comes to my mind. One is consistency. Second is the reproducibility that comes along with if you are able to play with the machine in a regular basis, not just one per day, just two or three per day. For my personal history as a urologist, I did laparoscopic radical prostatectomy. The last one last almost eight hours, and I said, "Okay, never more." If you are able to use a machine, and I link it with the cost issue, on a regular basis, you're going to increase that 2% to the ceiling.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Okay. Next question. David Lewis.

David Lewis
Analyst, Morgan Stanley

Ryan, can we ask two questions?

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

You can follow, yeah.

David Lewis
Analyst, Morgan Stanley

Okay. It's David Lewis from Morgan Stanley. I just got two quick questions. The first is, gentlemen, you've described the advantages of open console system this afternoon, as well as a pedestal-based system. Can you discuss any disadvantages with either an open console and a pedestal-based system? I had a quick follow-up.

Daniel Portnoy
General Surgeon, Duke University

I think there's pros and cons to everything that we do in life. It may vary from individual to individual. I think in a closed system, perhaps your focus is solely on the operative field, and there's no distractions around you, et cetera. To some individuals, that may be very critical to them. For me, I personally need to know what's going on across the entire OR space and be able to transition from big picture down to that limited space. I don't see many disadvantages, frankly. I do think that for some individuals, perhaps by not having their vision solely focused in that one space could be a disadvantage. The size of the monitor is such that I think that it's really encompassing. It's almost as you're in that cockpit, if you will.

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

Until now, there's only one way, right? Having two ways and then having many other options enter in both directions, allows us as a field to learn what's best for each thing that we do. Again, I see this as an opportunity to actually grow the field. Okay. That's because, therefore, the closed console concept is going to keep going, and the open console is now coming. How are we going to perfect each for various operations? Having modular system has unlimited ways you could put the stations, right? Very challenging if you think about the permutations of how to go do it.

That's why having a group here that is thinking it through, having leaders in surgery that have been doing very advanced robotic surgery now trying to figure out what is the best advantage to take of the modular system that allows us to go and figure it out. For guys like me, I really only do two operations. Therefore, for me, I'm going to go figure out exactly where to put the modules, and my team is going to dock very quickly simply because every day that's all I do. I think that's going to come along. Every time we invent a new operation that should be robotic, though, and get indication for it, we're going to need to go figure out how we're going to put it together, and we're going to learn whether it's better or not better.

I think the possibilities are enormous, and I look forward to the challenge of figuring out how to go do it better within each system.

Rubén Olivares
Urologist, Clinica Santa Maria

I found accounts of the open console, and that leads me to give you an practical tip. Never face to the main entrance of the OR because it can reflect the light. Every time that somebody open the door, you're going to reflect the light.

David Lewis
Analyst, Morgan Stanley

Just a quick follow-up. All of you talked about the U.S. Surgical have been making instruments for 40 years, and they're instruments you've all grown up with. To your point, these instruments that are on the system are they the same as the instruments you've been using for 10 or 20 years? Are they different now they're wristed in your mind? How important is having wristed stapling and energy devices? Thank you.

Daniel Portnoy
General Surgeon, Duke University

I think wristed devices, every procedure has different moments where you need the right tool for the job, so to speak, and not every single instant needs a wristed instrument, but a lot of what we do needs a wristed instrument. I think it's very beneficial in that regard. Some of those factors that Dr. Fong was alluding to about the unexpected uh-oh in the OR that he said maybe a hole in the vena cava where you'd convert to open and have big complications as a result of a big open procedure. Wrists are very enabling to allow you to comfortably fix that sort of problem. Thus far, in my experience in the lab, we've been able to use wristed instruments and use instruments that are very comfortable to me to use because they feel like the instruments that I've been using.

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

When we talk about the U.S. Surgical staplers. The current generation staplers are very different than the first generation. I want to remind everyone that some of the first-generation staplers still exist. Okay. One of the very best staplers ever made was a 30-millimeter end size vascular stapling instrument, only has two lines of staples, but works amazing. Okay. It has no wrist, and it has no articulation. When I do open surgery, every now and then, I still use it because it's the right tool for that right moment. Okay. It's also the least expensive stapler on the market. Okay.

It comes back to this, is that having a whole panel of staplers that you can use, some that maybe just articulated, some that may be wristed, some that maybe other things that we don't know even yet because they're in development. Allows us options and knowing the price points of each one of these and trying to figure out what the tool set is. That's why when I write atlases now, it says not just how to go do the operation at the surgical field. Okay. It is about the tool set, what tools should be nearby. It is about the orchestration and the positioning, and then it is about the operation step by step. All of those are now permutations of how we go and do the best operation for our patients. Again, having options makes the whole field better.

Rubén Olivares
Urologist, Clinica Santa Maria

Actually, I have no experience using a stapler during my clinical practice, but I will love in the future, start my cystectomy program using the new tools.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Take one more question. Bob Hopkins.

Speaker 21

Oh, sorry. I was wondering if I could get your opinion on the modularity concept. Could that potentially present some sort of logistical challenges in the hospital, rolling around different modules into different operating rooms? I recognize it's a potential advantage in a lot of ways, but do you think there'll be logistical challenges on that front? Secondarily, I was just curious if you could comment a little bit on the decision-making process going forward around robotic platforms. How are you going to weigh sort of cost and efficiencies against just pure functionality and image quality and more sort of clinically related items?

Daniel Portnoy
General Surgeon, Duke University

Sure. I guess, every day in the OR, we're sort of weighing cost and functionality and all of that, and that certainly comes into play. I think that even in every little micro, I think Dr. Fong just alluded to using low-cost staplers at times, and I think all of us in our operations are getting more and more scrutinized by our systems to kind of manage cost and maintain cost. Our choice of devices and when to use them are certainly critical in that, and that's where it's great to have a platform that is overall working to bring the robotic costs in line with laparoscopy.

I think that'll make our choices much more broad for our patients and allow us to bring a robotic platform that we're up here because most of us think robotics brings advantages to our patients, but we're limited in using it around cost sometimes. If we can mitigate some of that cost and bring the advantages of robotics, that's certainly fantastic. As far as the modular platform, I'm certain that it's like anything else. There's pros and cons of everything in life. We're going to have to go through learning a little bit of the dance of the OR anytime that you move patients in and out and equipment in and out. There's a little bit of an orchestration to that to do that efficiently.

If we're able to improve the overall access of robotics within the system, then I think we get that dance down and do it very efficiently. If you're doing one robotic case a day, well, your turnover times and all those things just aren't very efficient. If cost and everything lines up, access lines up such that we're doing most or all of our cases robotically, well, we really start to get those things down, it really becomes less of an issue because it just becomes our culture, our pattern, our routine.

Yuman Fong
Chair of Department of Surgery, City of Hope Medical Center

Data is good. I just helped run a big AI conference in Los Angeles where we looked at all the different ways where data captured, either through the electronic medical record, through sensors, through optics, through whatever is going to be used in healthcare in the next five years. The ability for us now to go sort out what instruments were opened and what was used, and to be able to list surgeon A, B, C, and D for the same CPT code, how much they spent, and how long the patient stayed in the hospital, and what complications they have, that's a great driving force to value, okay? That's because surgeons are going to figure out that they're spending too much for no value because their outcomes aren't any better. As administrator, I look at these all day. Okay?

How are we going to go capture data from the robots? I think there's a whole future coming on this platform to go think about this. I look forward to seeing how all these data are going to be captured to help us decide what are the next tools that are of value, what are the next tools that are important for safety or for only rare occasions that we actually need to use when those occasions come up, and what are the times that we need to go and think about OR efficiency, not just from a how do we go fit as many cases in the right slots, but what does the staffing look like? Where do they sit, and how do they interact with each of the arms, and what instruments should only be opened if necessary.

I think that we're going to be inundated with data, and hopefully, we'll analyze it for good.

Rubén Olivares
Urologist, Clinica Santa Maria

I think that the separate arms of the modularity is not a problem. The first time that I came over here to play with the prototype, I tried to do all the things by myself. I mean, try to move around with the arm draped just by myself, and it's very easy to try and to play with it. I don't think that it will be a problem.

Carla Peron
VP of Medical Affairs, Medtronic

Yeah, just an additional comment. I think you brought the modularity brings a lot of options, and with those options, there is different stages and probably different quality of data that needs to be analyzed. I think that refers back to what Bob presented about the journey to the future, and it's going to be exciting new challenges for us in the medical field overall.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Great. Yeah. We'll end there. Thank you. Thank you, surgeons. Thank you, Carla. Really appreciate your participation today. Thank you.

Pito Chickering
Analyst, Deutsche Bank

Thank you.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Yeah. Okay, so before we start, the next session, just a bit of logistics, for those of you in the room. For the sell-side analysts who have that lab on their badge that I talked about earlier, I ask that in about 5 minutes, so at about 5 to the top of the hour, that you gather by the doors over here, to my left, your right, so that we can get you down, to the operating room. Now we'll move into the procedure portion of the event, and there'll be two parts to this. Given the procedure that's going to be conducted in the operating room next door runs about 3 hours. We're first going to show you a highlight video of the procedure so you can get an appreciation for the entire procedure. We'll go to the lab, to see the live procedure.

The sell-side analysts that have "lab" on their badge, they'll be in the room. For the rest of us, we'll be looking at the big screen here to watch the procedure. For this next segment, I'd like to introduce you to two people. First is Dr. Steven Shichman. He's the Executive Director of where we are today, here at CESC at Hartford HealthCare. Dr. Shichman will be narrating the video and the live look-in. Also, I want to introduce you to Joseph Wagner, MD. Dr. Wagner is the Director of Robotic Surgery here at Hartford HealthCare, and he's going to be the surgeon performing the procedure today. Please welcome Dr. Shichman to the stage. Dr. Shichman.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

I'll let those on.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Yeah.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

It's not

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

There we go.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Good afternoon. I'm not going to read through this disclaimer here. What I'm going to do in the first part of this session is just give you an overview of the procedure. As Ryan stated, that this is about a 3-hour procedure, I'm just going to take you through what the procedure is, what you'll be visualizing, and hopefully, it'll make some sense for you and understand the anatomy. What you see to the right is Dr. Wagner sitting at the console, and what he's doing right there is exposing the prostate. As you know, all these trocars are put in intra-abdominally, through the abdomen. The prostate sits in the peritoneal space. It's not in the abdominal cavity, we have to get access to that region. Here, he's working behind the bladder and using a posterior approach to expose the seminal vesicles and the vas deferens.

Now, on the right, he's doing a sampling of the lymph nodes on the pelvic sidewall, this is the region where prostate cancer can spread. We sample those lymph nodes. You'll just see him working with his left hand with a Maryland forceps in the right, now you see the assistant placing a clip to put it over blood vessels and some lymphatic channels. Here's an external view of the room, just similar to what you'll see today. It's easy access for that assistant coming in. Here's some more of the lymph nodes. These are the obturator lymph nodes that are being removed. Once that portion of the procedure is done, sometimes we do that before taking out the prostate or after, we have to expose the prostate. What he's doing now is dropping the bladder.

Now, the prostate sits under the pubic bone. Remember, again, that's not in the intraperitoneal space, so we have to drop the bladder off of the anterior abdominal wall, and the pubic bone's up here. What we're doing is just dropping down all of these avascular attachments that don't have blood vessels and working through this tissue. Here, he's using some monopole electrocautery with his scissors and just sweeping these tissues down. He's working on the left side of the prostate. Now, what you see here is the prostate right in the middle and the fat overlying the prostate. Here, he's opening up the fascia or endopelvic fascia. It's the area where the prostate is covered by this fascia on the pelvic sidewall and just opening that up so we can get to the side of the prostate and more posterior on the prostate.

To the right, you see the external view of the arms working. Now he's working at the bladder neck, and this is where the bladder connects to the prostate. Remember, our bladder is the reservoir that holds our urine, and the voiding channel of the urethra goes right through the center of the prostate. We have to disconnect the bladder from the top of the prostate, and he's working through that anterior bladder neck, and you'll see him open into the bladder neck or the urethra, and that's the Foley catheter that's going through the urethra, and it's just being lifted up now. He's opened up the anterior portion, and now he's going to divide the posterior aspect right here, and that's the posterior aspect of the bladder neck.

Now he's going to come down to that under area or the posterior aspect of the prostate to where those seminal vesicles were that he dissected out before. You'll see he's working with his left hand. It's called a Maryland forceps. In his right hand, you'll see that's his extra arm that's coming in from the side, which will be used as a retractor. You'll see a different arm coming in in a moment. That's his scissors on the right side. What's going on now is this is the pedicle of the prostate. These are the blood vessels that supply the base of the prostate.

What you'll see here, typically, we don't use any electrocautery or energy because we don't want to damage the nerves going along the side that supply the erectile function to the male. We typically use clips coming across these vascular pedicles, because in real life, these bleed quite a lot, and we want to clip those and then sharply cut them on this side of the clip. The prostate's being held up here. The neurovascular bundle, or those important nerves, run along the side here. Just to remember, when we're doing prostate operations, two of the major issues are we want to preserve potency, or erections in the male, and also the continence. Again, here he's placing another clip on that pedicle, and then he'll cut right on this side of the pedicle. This is on the left side of the prostate.

He's working all the way down. We've shifted over to the right side of the prostate, doing the same thing. We're just clipping those pedicles, dropping the neurovascular bundle down. This is the prostate here, the wall of the prostate. This is a very narrow space that we're working on. It's very hard to appreciate how small this area is. Again, remainder of the pedicle on the right side being clipped. We're going to divide it, that will probably be most of the pedicle that we'll drop off. We're almost down to the apex of the prostate, all the way down to where the prostate goes back into the urethra. Right here is the anterior wall of the rectum. We have to be very careful, because obviously, we don't want to get into the anterior wall of the rectum.

If that happens, if we can't fix it, the patient has to get a temporary colostomy. Here we're isolating the apex of the prostate, dropping off those important nerves to the side and just clearing out all this area here. Now he's going to isolate the veins that drain back from the pelvis right across the top of the prostate. Here you see the foot pedals. Once we isolate these veins, we have to suture ligate them or put a suture across them, because these will bleed profusely as well. We place a stitch across there and then tie this down with a slipknot to secure this, and then we're going to cut on this side, the prostate side, because this stays with the patient. This is the undersurface of the pubic bone right up here.

We're working all the way under the pubic bone at a very narrow space. Once we cut through here, then we get the anterior aspect of the urethra, again, on the other side of the prostate. Remember, this was the bladder side, and then this is the opposite side, and that's the urethra, the voiding channel that goes right through the prostate. Just to orient people again, we're looking from the belly button down into the pelvis. The camera's in just above the belly button on this cadaver and pointed down in the pelvis under the pubic bone. He's dissecting down right down to the urethra that he's going to isolate, and you'll see him isolate. The Foley catheter of the urethra is right here. Again, right under that is the anterior wall of the rectum.

It's a very meticulous dissection, and what we can't appreciate is that this is a very small area, and the depth perception is very important here. Dr. Wagner sees in three dimension, where we're just looking at this two dimension, and we can't appreciate the depth perception, though we can infer it. But he can interpret it much better with his 3D vision. There's the posterior wall of the urethra, which is being cut. Once that's released, you have just some fibers attaching the back of the urethra and the prostate to the rectum, which are very minimal, and you could just cut those. Here he's putting in a stay suture, because once you cut this in real life, this springs back under the pelvis, and it's very hard to retract then when you want to do your anastomosis or sew this back together.

We put in a stitch before we fully transect it. Once that stitch is in, he'll now go and transect the posterior aspect of the urethra, and you'll see there's just a few wispy fibers that he can cut. Again, we don't like to use much cautery here or energy because we don't want to damage any of the neurovascular bundles that are running on either side, and importantly, the anterior wall of the rectum. In a moment, you'll see the prostate fully released. When we used to do these laparoscopically, everything was doable. It's still very difficult up to the time of this point in the procedure. This is when it gets really hard, when you have to sew this back together. What we're doing here is we're going to sew the bladder neck.

Here's the opening in the bladder, and we're going to put this running suture. This is at the 5:00 position. If you can imagine a clock, we call it the 5:00 position. This is going to go through the urethra. We use the Foley catheter to guide that needle to make sure we don't back wall or catch on the other side of the side that we're stitching on. This is a running suture. We do this in a running suture, so we get a watertight closure. Some people do interrupt it, but I think almost everyone now uses a running suture. You'll see once this suture is in, and we'll jump forward, how we cinch up this suture, and we bring the bladder down to here. We don't want to stretch this too much because we can tear that very easily.

Here he is tightening up these sutures to bring this anastomosis together. Once we run that side, we finish running with the other side. These two sutures are tied together, and that was the posterior aspect going from this side, up coming around here. Now he's coming around this side, running this suture back up. You'll see in a moment that all we have to close is the anterior portion, which is relatively easy. He'll bring this last suture through and then tie this one to here, and it'll be all complete. You can see how that's closing up very nicely. This is very reproducible. It's very easy with, again, these wristed instruments. You have added degrees of freedom over laparoscopy with any robotic system where you have these endo wrists.

Here's the bladder hooked up to the urethra down here, and the Foley catheter is in, and we're just filling the bladder to make sure that we have a tight seal there. With that, I think we're going to go in a moment to live surgery and see where we are downstairs. Okay. Pepe, can you hear me?

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

can hear you. I don't know about the term live surgery, but I'll let it go.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

We can't hear you too good. Let's see. He's lifting up on his seminal vesicles, and he looks like he's got the bladder neck down, and he's going to be working on his pedicle. Again, we're looking down from the belly button into the pelvis here. Now he's grabbing the left side on his seminal vesicle, which is down at the left base. This is the pedicle coming up here to the prostate. He's going to make some openings here. He's going to sweep down his neurovascular bundles there. Can we see if we can get Dr. Wagner's audio a little?

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Can you hear me better now, Steve?

Steven Shichman
Executive Director, CESC, Hartford HealthCare

A little better.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Okay. They're going to make some more adjustments. I'm going to stop operating for a minute.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

I see they're trying to work on that.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

He's adjusting his mic right now on him and adjusting the volume.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

That sounds a little better.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All right. They're holding the mic by my face right now, so we'll see how that rolls. I was going to say, I don't know about the term live surgery. I'm going to let it go.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Yeah. I wouldn't call this live surgery. We don't want to read into that too much with the cadaver.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Right now, I'm taking the pedicle on the left-hand side.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Pepe, I wish you can hear. He has a great sense of humor. We've actually been working together for, believe it or not, I just added it up at 31 years. I know his moves pretty well.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All that. Like I said, the bundle down here. Pete is going to come in and put another clip for me right here. You were saying before, it's important here not to use very much force at all.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

He's just instructing his bedside assistant where he wants those clips placed on the pedicle. We try to do this as realistically as possible if this was a real patient, and we have to preserve these bundles. Years ago, when people started doing these procedures, when we started doing these procedures, we would use electric cautery going through these pedicles. When we didn't really fully understand how important it was to avoid using energy here, so we didn't damage those neurovascular bundles.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

I'm sweeping the neurovascular bundle down off of the right-hand side.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Yep. That's what you're.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Rectum down here that I've already-

Steven Shichman
Executive Director, CESC, Hartford HealthCare

The rectum's right there, and he's just releasing the neurovascular bundle right here.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Yep. Yeah.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Pepe, did you do lymph nodes already? What you can see up here at the top screen is, it looks like the camera port, if I'm not mistaken, is coming between the patient's legs. The patient's head is down here, and they're in a severe Trendelenburg with their head tilted down. You have two robot arms on the right side of the patient. There's one robot arm coming in on the left side of the patient. There's another trocar that the assistant is using to the left of that left-sided robot arm. There are five trocars in the patient's abdomen with one right in the middle holding the camera, two on the right, and then one robot arm on the left.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

I've squeezed pretty much on both sides, both neurovascular bundles. I've started raising things up. I'm going to pull it down.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Both of the neurovascular bundles are taken down, and he's just finishing up the attachments more at the distal aspect of the prostate here.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Yeah. That's it? Okay.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

This was where he opened the endopelvic fascia down here. That's that envelope that covers the pelvic sidewall. This, if you're looking in, this is the inside of our pelvic sidewall here. The rectum down here.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

What's it? This one has to go on here. Probably.

Yeah. A little closer to the.

Okay.

Yeah. You guys want me to stop or?

We have to change the switch.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Yeah, Pepe, why don't you stop for a second and put the mic on?

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All right. I can't see, so you guys go ahead.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

All right. That's a lot better. Pepe, can you still hear me?

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Yeah, I can hear you fine, Steve.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

All right. Did you do lymph nodes?

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

No, we did not. I'm going to do those at the end.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Okay, good.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Sounds good.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

This is actually quite typical in real live surgery. In the operating room, we televise a lot of cases.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

It's good?

Steven Shichman
Executive Director, CESC, Hartford HealthCare

from our robotic rooms, and no matter how much we work at it, there's always some little glitches like this, but not a big deal.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Steve, is that better?

Steven Shichman
Executive Director, CESC, Hartford HealthCare

It just was before.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

It has to be, though.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Now it's great.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Somewhere.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Now it's great.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Now it's okay?

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Now it's great. Thank you.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All right, good. I'm pulling posterior, sort of cranial posterior on the seminal vesicles and vas now. I'm going to finish releasing the veil and the bundles on either side. Here's the bundle going out this way. That looks great on this side. You see where it's sort of tuckered here and here. Those are the puboprostatic ligaments there and there, and the dorsal vein is sort of in between it.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

So-

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

I'm going to cheat maybe another cut or two there. That'll be it.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

This is the pubic bone under here, and these are these little ligaments that hold the prostate to the under surface of the pubis. There's these large veins that run right between here, which he'll throw a suture through. I don't know if he will right now.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All right. I'll take two needle drivers, please. Now we're going to switch out the instruments, so we have a bipolar in our left hand, scissors in our right hand. They're going to switch those out, and we're going to exchange those for needle drivers. Chris, just make sure your cautery cord is, yeah, off. Yeah. We'll throw a stitch on the dorsal vein.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

This is a good view right at the top where you can see the console right adjacent to the table, and Dr. Wagner is just looking straight off here at the table so he can monitor what's going on here.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Good. All right. I'll take a stitch. 0, please. Vicryl.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Again, this is where the stitch is going to come right across here, around these large veins above the urethra, and then he'll tie a slipknot down to secure those veins.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Chris is just putting a catheter. That's a Foley catheter coming in through the penis into the urethra. He's putting that in just to make sure I don't put a stitch across the urethra. What I do is I sort of place the needle like I just did on the prostate to make sure I have it sort of going parallel to the urethra. Sort of like what you do laparoscopically. Make sure I have a good angle on it.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

What that is, you want to make sure you're coming straight across, and it's not angled down or up. If it's angled down, you can catch the urethra going to the urethra. If it's angled up, you're going through the veins and not around the veins. It's very important you throw it very parallel, and it's a little art to doing that. When he ties these down, one of the advantages, just to go through it, when the other surgeons were talking about wristed instruments. In laparoscopy, no matter who makes the instruments, you have four degrees of freedom, and you can just go up and down, side to side, in and out, and you can twist. Here, we have those added degrees of freedom with a wristed instrument, what you see here.

That gives you tremendous advantages when you're trying to do reconstructive procedures or suture or tie knots. This is just a slipknot he's using to just cinch down on there.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Cut. Much toward my left as you can, Chris. No, no.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

You got to move your right hand a little bit, Pepe. There you go.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Yeah, no. He's using a different assistant port right now.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Oh.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All right. Take that guy out. Good. All right, pull the Foley back a little bit for me, Chris, so it's not so torqued up. Good. I'll take the bipolar and scissor again. Good.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

I can't stress enough the value when you talk about the things of the advantages of robotics. Number one, Dr. Wagner is seeing in three dimensions. He has that depth perception. He has a magnification of 10 times. Again, the added degrees of freedom with the wristed instruments is really invaluable. When a surgeon works, when we're standing at a table and working with our open arms and our wrists and our elbows and our hands and our shoulder movements, we actually have up to 28 degrees of freedom. When we go to laparoscopy, we go down to just four degrees of freedom, it's a tremendous step backwards. Just adding a few degrees of freedom really opens up a whole new world for us in terms of reconstruction. It's easy to cut things out laparoscopically, but it's really hard to put things back together very well.

We can do it much better with these added degrees of freedom.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Bipolar. Good. All right. Now that we've got the dorsal vein controlled, I usually do this with some sort of combination of cautery and sharp. I start off with cautery. Once I'm pretty much through the dorsal vein, you see that give there a little bit? Now I'll do it more sharply.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Now he's coming right down on the anterior wall of the urethra. He's gone through the venous structures.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

A lot of times, just because this is so wide, this stitch will give, I'll put another stitch on afterwards. Now that I'm through most of the dorsal vein, I'm going to let go of the seminal vesicles and vasa. Now I'm going to grab the anterior prostate and pull that back, that's going to give me more stretch. Now I just flipped my scissors over so I'm pointing down instead of up. Try to push that back a little bit. This is going to be our urethra now that we're about to go through. There you see the catheter again.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Again, he's through the anterior wall of the urethra.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

You can pull that back a little bit, Chris. Yep.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

You've got a little posterior wall to go through, then you have the attachments to the anterior wall of the rectum, the rectourethralis, and a lot of that may have been dropped off already when he approached this posteriorly, some of it, depending on distally went.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Maybe what we'll do, guys, is just come in with my right hand with the needle driver and not the left. All right. Needle driver.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Now he's going to put in that anchoring suture because, again, the urethra will retract.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

What I would do is, in real life, if that stitch loosened up like it did, then I'll put another stitch in if there was bleeding.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Talking about this stitch right here.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Yeah. Sometimes there is, sometimes there isn't. Sometimes what I do is I don't even put that stitch in. I just cut that cold and let it bleed, and then control the bleeding afterwards, just because I can get a little bit more urethral length doing that. Stay stitch, yeah.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

This is a very important part of the operation for us when we're doing this.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

You got it.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

I know a lot of these tissues, it's hard for people to identify what they are, but it's really important to preserve these.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

The driver when you're ready.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

vascular bundles on the side, and this urethral integrity, and divide it in a way that you know we can reconstruct it well. Because again, there's so much.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Fully back

Steven Shichman
Executive Director, CESC, Hartford HealthCare

morbidity on that patient.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

And out.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

revolves around how we handle the tissues in this area. That's that stay suture that will help him when this urethra springs back. In a live patient.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

I'll take the scissors again

Steven Shichman
Executive Director, CESC, Hartford HealthCare

it really springs back significantly more than you'll see here.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

I think what I'll do too is I'll get rid of that stitch, Chris, just because it's going to be a pain in the neck when we're sewing later. I'll get it, though.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

We have about two more minutes, and we'll be wrapping up, okay?

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All right. Sure.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

After you transect that, if you want to just start looking at the sidewall, whatever you want to do. However you want to approach it.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Yeah. Sounds good. I'll get it with my scissors, Chris, yeah. What I'll do, Steve, then is I'll cut this and then just show what the next steps are going to be.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Great. Yeah. Perfect. We just have two minutes, so just give a quick overview after you cut it.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Yeah. You got it.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

nice just to see the sidewall anatomy.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

Now I'm cutting the posterior urethra. Now we have to just cut the rectourethralis. Good.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

All right. The prostate's completely freed now.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

The prostate's gone. We'll just pick that up there, and we'll fish that out later. Then now the operation would be to sew our bladder, which is down here. Our bladder opening is right there. See it?

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Yep.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

That's our bladder opening. We have to sew that down to our urethra that sort of took off like the head of a turtle down here, but it's down in there. I have to sew that to that, and we put a catheter in, and then when we're done doing that, if I hold this up, this is the medial umbilical ligament. I can just show you really quickly.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

This is the inside of the pelvic sidewall, and deep inside of there, that's where we look at the lymph nodes where prostate cancer.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All this yellow fatty stuff right here is all the lymph nodes. All this would come off, all this stuff here and here, and I would do that down to See if I can show you the nerve. Might not be able to do it without getting the nodes off first. There's the artery. There's the vein.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

That's the artery and vein coming to the leg. Going right down when the aorta splits, it goes down the side, right into our thigh.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

That's it.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

He's going to go deep and look at the obturator nerve. Pepe, I think we're going to wrap up now.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All right. Sounds good. Actually, that was a flash of it there.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

We're all set on time, I think. Thanks for the great demonstration. We appreciate it.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

All right. Thanks.

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Ryan, I guess we'll hand it back over to you.

Pito Chickering
Analyst, Deutsche Bank

Should we break?

Steven Shichman
Executive Director, CESC, Hartford HealthCare

Oh, okay. Good. That's all right. We're going to take a quick break, about 10 minutes. 10-minute break. If you want, there's refreshments in the back of the room and off to the side. 10 minutes, and we'll reconvene.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Okay, we're going to get started. Could you please take your seats?

Pito Chickering
Analyst, Deutsche Bank

Ladies and gentlemen, please take your seats so the program can continue. Please make your way back to your seats now.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

All right. We're going to get started. We're going to get started again. I believe our AV crew is going to, you'll see here shortly, they're going to keep a small screen going of the operating room down in the lower left-hand corner. You'll be able to keep watching. Keep in mind, as I said earlier, this is about a three-hour procedure. We're going to keep that going while we do the management Q&A up here. Now, we'll move to that. I'd like to invite Bob White, Megan Rosengarten, and Tracy Accardi to join me on stage.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

You need thread?

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

It's fine. Okay, we'll take first question. Let's do We got Larry Biegelsen back there in the middle.

To my right or your right?

Larry, right there.

Joseph Wagner
Director of Robotic Surgery, Hartford HealthCare

This one's good to go.

Larry Biegelsen
Analyst, Wells Fargo

Thanks. Larry Biegelsen, Wells Fargo. Just one, maybe for Bob, on pricing. You talked about reducing the cost of robotic surgery a lot today, but we didn't hear much in terms of specifics. Can you talk a little bit about the system pricing strategy, as well as the consumable strategy? How do you plan to achieve a lower price per procedure than what's currently available? Maybe give us a sense of a like for like procedure, because they vary widely. How much lower do you think you'll be than the competition? Thanks for taking the question.

Bob White
President of MITG Business, Medtronic

Yeah. Well, Larry, thanks for the question. I thought you'd be really pleased with the data I gave you around the schedule and the financial impact. I appreciate you wanting more than that. What we talked about was the need, clearly from the feedback of two things. One, how we drive down to a cost per procedure, right? I'm not going to give you specific procedures. Here's what you get for a prostatectomy. I want you to think about if you understand at the cost of lap for those procedures, that's where we need to get to. The elements that we get to there, I also gave you not just a clue, but a very direct comment that we're not going to give the robot away. This isn't about giving the robot away and then trying to make it up some other way.

We believe that the cost of acquisition, again, as I mentioned to you, is a large upfront capital cost is bearable if it can be translated on a total cost of ownership for that institution, so on a cost per procedure. Elements involved there certainly are things like the modularity of the system, certainly the consumables. The end effectors come into a play on that as well. Certainly, how the system is utilized comes into a play on that. It's probably a bit premature to go into the specifics of the model, and I'm certainly not going to say vis-a-vis somebody else who's already in the marketplace. I think those are the elements that we're going to work with there.

Larry Biegelsen
Analyst, Wells Fargo

Thanks.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Let's go to Vijay up front here.

Vijay Kumar
Analyst, Evercore ISI

Vijay Kumar from Evercore ISI. A couple of questions from me, Bob. One, when you look at your modeling assumptions, 50 basis points for next fiscal, 150, 250, is that all incremental to your underlying 4% growth rate? I'm just trying to tie that into the fact that some of the survey work you guys have done, 60%-70% physicians saying they would recommend your system. That would imply a much bigger number, in terms of growth rates. If you look at 1,200 systems being placed in the market right now, 60% of them likely to recommend, I would come up with some pretty big numbers. I'm just trying to reconcile those modeling assumptions versus what the survey is showing. Then I had a follow-up.

Bob White
President of MITG Business, Medtronic

Okay. First one, Vijay, thanks for the question. When I talked about less than 50 bips in that first year, let's remember, as we sit here today, we still don't have a system approved to market in anywhere in the world, right? We're going to move our way into that. We're also going to ensure that we have a phenomenal customer experience as we move into that. I think what I would do is take the way we've guided MITG to the street, and then use accordingly those basis points as truly incremental growth to what we've guided you to. We feel good about that, and we think there's obviously a lot of runway ahead of that. That's the way I think about it. Does that make sense? Yeah.

Vijay Kumar
Analyst, Evercore ISI

As a follow-up, I think the one thing that you guys mentioned, the system is modular, and it fits in with your existing FT-10, the towers. Does it mean your existing installed base, you can just take one of these systems and plug in with the tower? What's the installed base of your FT-10 towers right now?

Bob White
President of MITG Business, Medtronic

Yeah, sure. It's a very good question, actually. We have several thousand FT-10 generators installed around the world. Those are installed in operating rooms that are using for minimally invasive surgery. You certainly have the opportunity, although we don't suspect that that will be the model. We think when people acquire a robotic system from Medtronic, once it's approved, that will come with the FT-10, an additional one as part and parcel of that system. You're right, and it's the same system, and Megan talked about that intentionally because of the tools that plug into those FT-10s. Let's say, for example, you've got a system where thatLap tower that Megan described as part of the robotic-assisted offering can be used in a procedure where there aren't any robotics in place. In this case, I have an operating room that I haven't used for minimally invasive surgery.

I put in a robotic tower that has a lap tower on it, and in fact, then I can start using our LigaSure devices right off of that FT10.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Thanks. Let's go to Matt Miksic.

Matt Miksic
Analyst, Credit Suisse

Thanks very much. Matt Miksic with Credit Suisse. If I could, just one follow-up to Larry's question about the price. You said something about not giving them away for benefit or something like that. I think in the past couple of quarters, you may have talked a little bit about that model that's been successful in spine, maybe being open to that, or if you could maybe just clarify that a little bit.

Bob White
President of MITG Business, Medtronic

Sure.

Matt Miksic
Analyst, Credit Suisse

I had one question just about visualization, if I could.

Bob White
President of MITG Business, Medtronic

Okay. I'll take the first one because I do think there's a misperception, for example, with Mazor, that we were giving away Mazor, and then we were trying to make it up on implants. That actually wasn't the model and isn't the model. What I believe we have the opportunity to do is a variety of commercial models ahead of us, right? Certainly, some of what you see in the marketplace today around operating leases and other things, you'd expect this. All three of us on stage have significant experience in large capital equipment. Those are pretty standard. To answer your question specifically, we'll look at all those models as we move into the marketplace that fits what's right for the customer. Does that clarify?

Matt Miksic
Analyst, Credit Suisse

Yeah, I think so. On visualization, just wondering, the VisionSense acquisition you made. We saw some of the technology at the booth at SAGES, and I'm just wondering how fluorescence imaging or that sort of thing falls into the strategy of building up this platform.

Bob White
President of MITG Business, Medtronic

Yeah, sure. You want to take it from the tech perspective?

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

Sure. Yes, we can pair on this, Tracy. The first piece, you've hit on something that obviously is on our mind and that we think about quite a lot as well is how do we best leverage the capabilities across Medtronic, including the recent acquisition with VisionSense. Our teams, Tracy's R&D team, and the R&D team at VisionSense do work very closely around what should that continuous innovation in that vector that Bob showed on the slide around visualization and navigation, and when do those things come together. Something that is an ongoing conversation with us. We also feel very strongly about our partnership with STORZ in terms of the pipeline of visualization products that we're going to have there. We have other things that are in development that are going to be ongoing product launches. I don't know, Tracy, do you.

Tracy Accardi
VP of Research and Development of Surgical Robotics, Medtronic

I would want to add that we will have an offering at launch that we will continue to build upon with the regular themes of innovation around visualization and navigation, as we mentioned, as well as those other three vectors, robotic system-based innovations and the data and analytics side. Those investments begin already, and our vision is to be able to continue to add value to this very high-value piece of technology.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Next question.

David Lewis.

David Lewis
Analyst, Morgan Stanley

Oh, sorry. David Lewis, Morgan Stanley. Just two questions for me, Bob or Megan. Bob, first thing, just regulatory. You gave us very appropriate timelines. If we think about these different geographies, should we assume some of those approvals come with multiple indications or single indications? Just help us understand how you're thinking about indication expansion as you enter these markets. Is it going to be one to start, or could it be two or three to start?

Bob White
President of MITG Business, Medtronic

Yeah. Do you want me to take both, this first question?

David Lewis
Analyst, Morgan Stanley

The next question just is, it is pretty clear that we are describing commercially as kind of a usage-based agreement leveraging your install base of instruments. I am just sort of curious, a lot of those instruments you have been using for 20-plus years, they are very high margins, fully depreciated, and you are going to transition those instruments into new articulating-wristed instruments. As you think about the margin profile, you have given us the growth profile of Medtronic through 2023. Is this a diluted enterprise to the corporation through 2023?

Bob White
President of MITG Business, Medtronic

Yeah. Sure. I'll take both questions, and Megan can jump in as well because as we think about I'll do the second one, David. On the capital equipment business, by definition, is different than the traditional margin profile of this business. That said, we think about this within both the scope of MITG and broader Medtronic, and we're going to manage our way through that, right? I would think that capital equipment is less margin-rich, if you will, than some of our other businesses. We absolutely see that we'll make those trade-offs to make sure we build this up and do this correctly. I think that's going to be fine.

David Lewis
Analyst, Morgan Stanley

Is it profitable on the bottom line before 2023?

Bob White
President of MITG Business, Medtronic

Oh, sure.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Can you repeat that? Is it profitable on the bottom line before FY 2023?

Bob White
President of MITG Business, Medtronic

Yeah.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Go ahead.

Bob White
President of MITG Business, Medtronic

The question regard I just want to make sure the usage based on the end effect. Could you repeat that question again? I'm not sure I understood it, because today we don't necessarily have multiple models, but I want to make sure I understand when you say usage based on our existing instruments.

David Lewis
Analyst, Morgan Stanley

Sure. Sorry. I think the assumption for a lot of investors is that you're going to place these systems in some cases, but you're going to do so on a multi-year-

Bob White
President of MITG Business, Medtronic

Oh, I see.

David Lewis
Analyst, Morgan Stanley

instrument-based or usage-based model for the instrumentation. The customer's not going to bear the cost of a $1 million piece of capital up front.

Bob White
President of MITG Business, Medtronic

That's what I was trying to debunk that, right? Again, I think it's a really important one to understand because customers have not told us that they shy away from spending $1 million-plus on capital equipment. They do if they can't get the overall cost for the system correct. System meaning cost per usage on it, right? I wouldn't want you to have the perception that we're going to place a bunch of capital and hope to make that up in end effector sales. That's it. Now, there are a lot of models in a lot of geographies that we're going to deploy commercially, right? I think we've got a lot of flexibility there. This idea of no upfront capital from our customers would not be a correct assumption. Your first question had to deal with regulatory approval in the markets, right?

I think it's fair to expect that the regulatory approval and the indications that are approved will vary by marketplace. Some may be single indications, some may be multiple indications, and a lot of that, as you know, depends on our work with those regulatory bodies as we go through it. It'll vary.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Okay. Let's go to Peter in the back.

Pito Chickering
Analyst, Deutsche Bank

Thanks. Pito Chickering , Deutsche Bank. Sort of two questions. The first one is to following up on the pricing questions. Is it fair to think about some of the cost reductions per treatment being across subsidization by placing consoles in all the ORs and getting reductions on the robotics costs by sort of cross-subsidizing within MIS and open?

Bob White
President of MITG Business, Medtronic

Is your question, do we think about cost reduction?

Pito Chickering
Analyst, Deutsche Bank

By selling lots of consoles across the different ORs that could reduce, theoretically, the robotic costs.

Bob White
President of MITG Business, Medtronic

Yeah.

Pito Chickering
Analyst, Deutsche Bank

because you're subsidizing in the other categories.

Bob White
President of MITG Business, Medtronic

Yeah. I don't think about it in terms of subsidizing, but what I do think about is customers have a broad-based relationship with Medtronic, and that broad-based relationship with Medtronic affords them an opportunity to look at the portfolio of products that we bring to the table. From that standpoint, I do think there's an opportunity from a customer standpoint to participate more broadly with Medtronic.

Pito Chickering
Analyst, Deutsche Bank

Okay. For a follow-up, for 2023, you guided to 200-250 basis points of revenue growth. Can you split out what part of that is procedure revenues versus placement revenues?

Bob White
President of MITG Business, Medtronic

Yeah. Thanks. I'm not going to go into details in terms of procedures versus capital.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Okay. Jason?

Speaker 22

Thanks. I just wanted to get back to the regulatory question. In the U.S., what do you anticipate the trials are going to look like? Then when you get clearance in two years, what will be the first indication?

Bob White
President of MITG Business, Medtronic

Yeah. I'll have Megan jump in on this question in terms of the regulatory, I think it's really important when we talked about our current best estimate as we think about the U.S. As you know, that's outside of our control. Megan, why don't you talk about.

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

Yeah.

Bob White
President of MITG Business, Medtronic

We've had multiple discussions with the agency, and so frame up the nature of those discussions.

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

The first thing that I wanted to mention, and some of us were talking about this on the break, is that the system that is designed that you saw today and the surgical instrumentation or the end effectors that come with that, those are designed across a full range of surgical indications and specialties. The things that you would think about for general surgery, colorectal, bariatric, thoracic, urology, and gynecology. That's what this system is designed and intended for use. As Bob mentioned before, the regulatory path varies by governing body and by geography, obviously, of when can we come to market with multiple indications or all indications at one time versus when does that look more sequential. That's the kind of first piece I would just want to clarify and put out there.

The other piece around, we've had several conversations, several meetings thus far. Let's talk about the FDA in particular, but also with other governing regulatory bodies around the world, in Europe, for example. We think that we have a pretty good sense of what's going to be required in terms of where there's going to be preclinical data required versus clinical data. We think we have a strong strategy around things like which procedures are going to require which type of data and also what the patient enrollment rate looks like for those studies. I'm not going to go into the details. I'm sure you can understand the why on all of those, of how many patients for each procedure and which procedure.

I think suffice to say, having had good conversations, we continue to have those conversations to pressure check that we're going in the right direction. Those things, like we said earlier, add up to the best estimate that we have right now is that 24 months from today from a U.S. standpoint.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Bob Hopkins.

Speaker 21

Just two quick things and I'll mention them both up front. First, in between now and the time that you start some of the data gathering and the clinical work, what needs to happen between now and then? What's the long pole in the tent preventing you from starting that tomorrow? What needs to be done? Secondly, some of the other robotic companies that have done clinical work have only needed to use five or 10 centers as part of their clinical trials. Is that a good rough estimate as to how many centers will be involved in your trials? Or is there a reason to believe that it could be dramatically different?

Bob White
President of MITG Business, Medtronic

Yeah. Let's take both. I'll have Megan jump in on the clinical. Well, why don't we take that one first, actually.

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

Yeah. I would actually say, Tracy, if you want to talk a little bit about the pilot versus pivotal, but the data. That question of between what's going on now, what you see today, and what does that look like to getting to clinical or human data collection, I think would be great.

Bob White
President of MITG Business, Medtronic

Yeah.

Tracy Accardi
VP of Research and Development of Surgical Robotics, Medtronic

I think it's probably very clear to you at this point that you're here today in the middle of our verification and validation process. The process that you see going on in the lab today is very much an exercise in gathering all the data that we need.

Bob White
President of MITG Business, Medtronic

Sorry, Tracy.

Tracy Accardi
VP of Research and Development of Surgical Robotics, Medtronic

Oh. I thought I could hear myself. Could you hear me before? The process that we're going through now is very much a planned step-by-step protocol for making sure we have all the data that we need for our submissions, both CE and for the preparation for the U.S. IDE. That's the runway between now and the submissions that you saw on our waterfall, and it's a full-on court press in that area.

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

I think mine is good. Yeah, you guys can hear me, right? I think the other question that we had here was around, where did it go? Where clinical sites. Right. Sorry, we're kind of asking that question. Again, I think we've got a really good strategy, a really good handle. One of the things that determines how many, what type of clinical sites that you have to have is, again, going back to that strategy of which procedures, how many patients. That says, well, where do you need that volume of procedures in order to get the patient enrollment that you need in a given time period to generate the data required for that particular clearance? I think we have a good strategy put in place on that. I'm not going to speak to the number of specific sites that are going on.

We always look at that as well as where can we flex that if there's going to be benefits or things are going to allow us, to be more confident or go faster with that.

Bob White
President of MITG Business, Medtronic

I think, Bob, the first part of your question, I'm sorry, was.

Speaker 21

Is there a reason to think it'd be dramatically different from what we've seen previously, though?

Bob White
President of MITG Business, Medtronic

He's asking Or go ahead, Bob. Can you ask it again?

Speaker 21

I was just asking, is there a reason to think that your number of centers required would be dramatically different from what we've seen with other competitors?

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

I'd answer that two way. Not a reason to think that it would be dramatically different in terms of required, right. The reason I say required is there are kind of two factors here. There are external regulatory bodies that we work with and understand what are the requirements and recommendations associated with that. Then there are internal Medtronic process around how do we feel about the data that needs to be required so that we have systems that stand up to the quality and reliability of ours. I think that's the only piece that I would say that depends, in terms of internal.

Bob White
President of MITG Business, Medtronic

I think that, because I want to make sure I answer both questions. Your first question kind of dealt with the long pole in the tent. What's involved? The way I'd have you think about that is, we're moving parallel on all the things that you'd think about, right? Quality, medical training, operations, all those elements are being progressed forward. Manufacturing, all of those elements are coming together. The long pole in the tent from my perspective is exactly where we are in the development process. Just making sure we get through a pre-clinical verification and validation and making sure that continues to go very well. All the other things are in play as we build up this robotics business. The good news is, not just us here on stage, we have a lot of experience in capital equipment. We understand how it works.

We understand what's involved. We understand the customer support model that's going to be required. Of course, we have, fortunately, not to get ahead of ourselves, but we have an amazing channel already in the marketplace, both from the surgical innovation sales reps that exist, but also, as I mentioned during the presentation, we train 9,000 surgeons every year. Net global infrastructure's in place and ready to engage. All of those we're working. Rick.

Rick Wise
Analyst, Stifel

A couple of questions about features of the system today, [tomorrow]. I keep meaning to ask, is there haptic feedback on the system and is it important, one? Two, do you need an integrated table? Is that important and part of the plans? Last sort of bigger picture, with the rise of automation, big data, all that stuff, is that contemplated as part of your vision for the future of the system?

Bob White
President of MITG Business, Medtronic

Yeah. Sure. Tracy.

Rick Wise
Analyst, Stifel

Thank you.

Bob White
President of MITG Business, Medtronic

Why don't you take both? I mean, they're both awesome questions. It's one we know the answers to.

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

Yes. I'll kind of start out with the haptic feedback question. You asked two questions, like does it matter and do you have it? I think you reversed them. I'd probably put them right at that order of does it matter. Similar to kind of what we were talking about earlier, we spent a lot of time around prototypes that have to do with haptic feedback sensors, and there's a lot of different versions of haptic feedback. There's just pure force. There's can you actually feel what a substrate feels like? All of these types of things. Safe to say that that's something that's kind of ongoing in terms of our development pipeline and that indeed we look at. With that caveat, we have made decisions not to have that, so to your question, because we've gotten feedback that it hasn't been necessary.

That's a broad generalization, and still looks at there are areas where we're saying, rather than do you have haptics or not, what's the meaningful problem that we're trying to solve? Do sensors and haptic feedback make a difference on that? That's a continuing part of that innovation in the vectors that we talked about before. I would say from a data and analytics, and Tracy, you want to hit on that one?

Tracy Accardi
VP of Research and Development of Surgical Robotics, Medtronic

Sure. We're very much convinced that the combination of the kind of procedure data that we'll have, the imaging that we'll have from being in the middle of the procedure, as well as the instrumentation activity that we know, combined with the ability to understand what the procedure was trying to accomplish and all these things can be put together in a data analytics environment that will make it possible to potentially make better clinical decisions. We're already started down that pathway. I'm not ready to talk about any specific areas. We're partnering with people that are thinking about that already. We're investing in it today, even though it won't be necessarily in our first launch, but it's something that we build into that regular cadence of development that we have in mind. That vector is very important to where we see ourselves going.

Speaker 21

The table.

Megan Rosengarten
VP and General Manager of Surgical Robotics Business, Medtronic

Oh, the table. Sorry, you were speaking to the integrated OR table, was that the question? Again, I know it's the same talk track, but accurate to say that we have looked at things that are integrated table, meaning the robotic arms are actually integrated in the table. We decide purposely to move to the pedestal mounted and the multi-cart system that you see before you today. We also look at things like the problem you're trying to solve sometimes, there are multiple ones, but with something like an integrated OR table or a moving one, is around when you do patient movement, right? When you're repositioning a patient during the procedure. I don't know if Tracy, if you want to talk a little bit about that.

We can't go into a ton of detail. I would say that that is a problem that we think about in the solution that you see here. There are multiple ways to answer that.

Tracy Accardi
VP of Research and Development of Surgical Robotics, Medtronic

Yeah, I would say that there's been so much work done in understanding by procedure what kind of positioning is required, and whether or not we can accomplish that with our robotic arm and be less dependent on the table to do any of that positioning for us. I think we've picked the right line in the middle in terms of what do you need to build into your arm so it can be capable of whatever is required. At this point, I think we're in a very comfortable position relative to what the robot's capable of doing and what the procedures require. It's less bed dependent than it might need to be otherwise.

Bob White
President of MITG Business, Medtronic

Okay.

Okay, Rob.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

I think we are going to stop there in order to keep us on schedule here. Thank you, Bob. Thank you, Megan. Thank you, Tracy.

Tracy Accardi
VP of Research and Development of Surgical Robotics, Medtronic

Thank you, guys.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Thank you.

Next up.

Mike, stay.

Omar Ishrak
CEO and Chairman, Medtronic

Yeah, go please.

Tracy Accardi
VP of Research and Development of Surgical Robotics, Medtronic

Should I leave it?

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

You can come. Next up, I'm going to invite our Chief Executive Officer and Chairman, Omar Ishrak, to the stage to say some closing remarks.

Omar Ishrak
CEO and Chairman, Medtronic

Okay. Well, it's a real pleasure to be here. It's great to be able to talk to you and meet you here on this occasion. I hope you enjoyed the day. I hope you got information, and hopefully, you are as excited as we are about the work that we're doing here. This robotic program has been perhaps one of our, not only most important, but heavily invested in programs that we've ever had. It's one that Medtronic and Covidien, the integration actually pulled it forward. Pulled it forward, meaning from a completeness perspective, and one that we think will be a real game changer for the company. We think about this not in one or two years, we think about it in 10 years. In 10 years, not just this robot, but other robots that we've got going will change the face of surgery.

It may even be longer than 10 years, but robotics being used in surgery and all kinds of different kinds of procedures will be something that's standard, and we will be in the middle of that. We will drive it not only through our robot, but through the instruments and high-value consumables and implants that go along with it. Still, the robot is perhaps, and this program is just one of many, and I think Mike shared with you right at the beginning of the day, the pipeline. You've heard me talk about the breadth of the pipeline and how excited I am, and how many things that there are coming along here at Medtronic, that I'm truly excited about. It really takes the company to a new level, a level that we've never had of this many products coming out in a fairly rapid sequence.

Other products with real catalysts in place which will continue this growth over time. People ask me all the time, what am I most excited about? I'm going to just speak of a few. I look at it in three categories. The first category are products that we've actually just launched or indications that we've had. Examples of that are certainly the Mazor Robot, which we launched in the beginning of the fiscal year, end of last fiscal year, which is beginning to pay dividends already. The TAVR low-risk approval and the Evolut PRO+ that just got approved. That's really driving significant growth in the TAVR market, and we're in the middle of expanding that market and creating it. Those are growth drivers that are right now. There are others, I'm just picking off a few.

If I look towards the end of the year and towards the second half of this fiscal year, there are some really exciting ones. In no particular order, I start with the Micra AV, which I just can't stop talking about because it's the extension of a product that has just beginning to disrupt the pacemaker industry market, an invention that the company was founded on 60 years ago. We think Micra AV will take the addressable population to 55% of the pacemaker population as opposed to 15% in the version today. In addition, the Micra, a number of other sort of stimulation type devices. There's the Percept DBS stimulator, which has the sensing capability of which I just last week had a real in-depth review of that program and learning how it works, and I'm telling you, that thing's exciting.

That's going to be a game changer and a game changer for the future. One that'll be pretty apparent towards the end of the fiscal year. We have the InterStim Micro, which is a 3 cc pelvic health device, which will also, in its own way, be disruptive when it comes out. Then finally, amongst the ones that I list amongst others is the 780G in diabetes, which will be launched towards the end of the fiscal year. We'll have new algorithms in it. We'll take the time and range sort of bar much higher than what it typically is today. In addition to all of that, it'll have upgradability through Bluetooth, which will make it into a platform for the future because the algorithms that we'll be using will continue to evolve.

That's line of sight to things that we're going in the next six to 24 months. Beyond that, we have some key catalysts, things like Ardian, results of which we will talk about early next year. We will talk about the results of clinical trials that we're conducting right now. The EV ICD, another program whose results will come through next year. The LINQ II, which is a product that we'll launch, and over time will create heart failure indications. I'm going to stop right there, but you can see that I can go on and on.

Not just about what we have today and what we have in the second half of the year that promises continued growth into next year, but the pipeline of broad developments that takes us beyond that. In addition to all of that, we of course have what we talked about today, which is the robot. Look, I couldn't be more excited about where Medtronic is today, about the pipeline that we have today, and where we're going in the future. There's something else that I'm excited about which you all know about, which is our future leadership. We recently announced that Geoff Martha would succeed me as CEO of Medtronic in about, when is it? April 27th, at the end of our fiscal year and the beginning of the next fiscal year. Look, I couldn't be more excited. A number of things.

First of all, the board went through a really thorough process. We went through a process of the last three or four years, going through this in detail. One of my objectives that I had when I came into Medtronic, other than sort of the company performance objectives, was to have an internal succession plan, a choice of internal candidates, and an internal candidate who succeeds me. I'm really thrilled that is possible and has been made possible through the work of our team overall and the board. Geoff's just a great choice. Geoff has had broad experience, he's had tremendous results, he has demonstrated a real connection to people. Most importantly of all, Geoff has been involved in the strategy of the company and has been core to creating it.

I look forward to continuity, I also look forward to change because the company today and in April of next year will be in a different place than where it was when I started. A completely different place. It's bigger, it's in a growth trajectory, it's got a full pipeline of products, we've got things established globally. We've got other initiatives in value-based healthcare and other things which we're much more sort of prudent about and sophisticated about than we were eight or nine years ago. That doesn't mean that there's no opportunity. There's even greater opportunity, I couldn't be more excited than to have a person like Geoff lead this, or Geoff himself to lead this. I don't know where it'll be, I know the company will go to the next level, I'm just thrilled about it.

Before I ask Geoff to come over, a word of thanks to the team today. A word that Megan, Tracy, Bob, and everyone else in the MITG team has taken us to where we are today. Now, of course, there's work to do. We've got a lot of work still to do, but this is a pretty big milestone. This is a pretty good milestone. We're at a point where your product really works. That's a big question in something as sophisticated as this with the software and hardware. Software and hardware from many multiple computers here work together in a seamless fashion without any sort of delays and hiccups and all of that kind of stuff. We still have some development to do, but the core integration has been done and risk retired.

It's a matter of getting experience, getting clinical experience, getting approvals, and these things will happen. I've got no doubt these things will happen. I've got zero doubt, in fact, these things will happen. It'll take time for us to establish ourselves to get the business models and the selling models right, and we'll learn as we go along. This is going to happen, I assure you. As I introduce Geoff, the other thing that I'm sure Geoff will comment on is the other robot that we have in place, the Mazor Robot in spine. We've learned a lot from that. We continue to learn from that, and I can tell you that the teams are talking a lot about that. There are different customers and different procedures, but the teams are learning from each other, and I'm sure Geoff will shed light on it.

With that, I'm going to ask Geoff to come over and say a few words, and then we'll open it up for Q&A. Just come on, Geoff.

Geoff Martha
President, Medtronic

Okay. Is this for you? All right. Thanks, Omar. This is the first time I've had the opportunity to see everyone since the announcement. I'd like to start off by saying what an honor it is to be named by the Medtronic board as Medtronic's next CEO. It's a very special company, and I really couldn't be more excited about all the opportunities which we'll talk about, but also the challenges. I enjoy the challenges. I enjoy the competition, and I'm really excited about it. I'm also excited about Brett Wall, who's going to be taking over RTG, who some of you will get a chance to see at NASS tomorrow. Brett is a guy who's committed to our patients first and foremost. He's committed to innovation. He's got a global mindset, and he's just a fierce competitor. I love that about Brett.

On top of all that, he's a colorful personality. Any of you who got to work with Brett, he's fun to work with. I think RTG is going to be in great hands as well, and I'm proud of what we've done at RTG, but I'm excited about where Brett's going to take it to new heights. I'm sure of that. I'm sure there will be a lot of questions around what are my thoughts and changes that we're going to put forth in broader Medtronic as I take on the leadership role. I'm not going to get into too much of that today.

I'd like to spend the next eight or nine months, so that kind of April-May timeframe, to do a lot of listening around the company, particularly the other business groups. I've been pretty focused on RTG over the last few years, and I want to get a little deeper into the other business groups and understand and develop my own point of view. More importantly, work with the other members of ExCom. This timing also works out with our strategic planning process. To go through that strategic planning process, I will be leading that process and make sure that we're all not just aligned or bought in, but committed to the strategy. As Omar said, there's going to be continuity here. Myself and Karen and Bob and others on the Executive Committee, we've been a part of this strategy. You're going to see continuity.

A couple of things I will comment on that I feel pretty comfortable with. One is the mission. The Medtronic mission is something that's sacred within Medtronic and has kept this company not just surviving, but thriving over 70 years. To build on that mission is something that's in our control and something that we'll continue to do. The other, we've got a lot of strategies out there that Omar's talked about, but a heavy dose of innovation. You're going to see, you see it already, a doubling down on innovation, and we're going to continue to do that. I think that's something that you can count on in terms of the innovation focus. The other thing, just shifting gears to today, I'd also like to congratulate Bob, Megan, and the MITG team, and others at Medtronic that have made today possible. It's a big milestone.

There's been a lot of progress. Very exciting chapter ahead. I can tell you, Omar mentioned Mazor. In parallel to all the work that Bob and his team have been doing, we've been working on launching the spine robot and also a smaller cranial robot behind that. Robotics is something that is going to be a big part of the company going forward. I think, I can tell you, the RTG team has learned a lot from the MITG team, and I think there's been vice versa as well. I think as we go forward, we're going to continue to learn from each other. You'll start to see technology platforms that cut across the company that I think will accelerate our follow-on offerings in the robotic space. This will be a commitment for the company.

Look, at Medtronic, with our resources, I think we can do a lot of things, but we can't do everything. This is going to be something we do. This is going to be something that we went at. I'm comfortable with that. I have a lot to learn on the MITG robot here. I have a very clear vision on where the spine robotics market's going. You're going to see us separate ourselves from our competition and set the market. We've changed the market dynamics in spine, and we're leading there. I'm sure that the MITG team is going to do the same in general surgery. It's very exciting. Finally, talking about innovation, the timing of this leadership transition is great. I got to thank Omar for all the work that he's done to set this whole thing up.

The timing's great because the overall pipeline that we have, and you saw the chart that just up there, I couldn't be more excited about that pipeline. I'd have, even in the last couple weeks, spent time with the other businesses getting a sense for some of the products that are coming out. It is a very exciting time. It's a very exciting time to be taking over because these things are going to be, these products, as you can see, a lot of innovation hitting in the back half of this fiscal year and in FY 2021 and beyond. You're starting to see that reflected in our level of confidence. Verbally, you got to see the body language and feel that our confidence is up. It's reflected in, I think, our performance. Our stock price has gone up a little bit. That's great.

The other thing is, I think there's still a lot of upside here because the level of conviction that I have about that pipeline, obviously, you don't, because I still think we're trading at a massive discount, and you haven't really bought into the story yet. We've made a lot of progress, but there's a lot of upside here. I intend to work with Bob and Karen and the others on ExCom and Omar to convince you of the value of this pipeline. With that, I'll turn it back to Omar.

Omar Ishrak
CEO and Chairman, Medtronic

Okay. Thanks, Geoff. What we'll do now, without further ado, is open this up for Q&A. I'm going to ask Bob and Karen Parkhill to come on up. We'll take seats here. I think, Ryan, you're going to conduct the Q&A? Okay.

Geoff Martha
President, Medtronic

Okay. Take a few minutes of questions. Vijay?

Vijay Kumar
Analyst, Evercore ISI

Thanks, guys. This is Vijay Kumar from Evercore. Maybe I'll start with the management transition here. This is a big event, and typically we've seen these events also coincide with a strategic change in directions, if you will. If I look at your balance sheet versus your peers, that's a very healthy balance sheet. Maybe some thoughts around capital deployment and how maybe some of those could change. As a follow-up, Karen, IRS tax rate, any clarity on where we are on tax rate going forward? Thank you.

Omar Ishrak
CEO and Chairman, Medtronic

I think, look, over the past few years, we've paid off the debt from the Covidien deal. Our balance sheet is strong. Our free cash flow generation is getting up there to a level where we want it to be. Continuing to grow with our earnings rate, which really gives us many options. I think, let's not confuse organic growth, which we have in place, with inorganic growth, which we can add to what we've talked about. You'll see that even within the next eight months. I'm sure Geoff, with his background, will look at it even more. I think our current thinking around tuck-in acquisitions is the way to go. I never rule anything out, like no one does.

Really, token acquisitions, there's enough opportunity there in the spaces in med tech that we're at, that we can add gaps to our existing areas, keep moving up to the top and the right in the [Wagner] space. That means get to higher and higher growth businesses, use some of the techniques that we're learning how to use, which are like these technologies like robotics, which tie to our existing products, take the growth level up of existing high-value products. I think we'll keep our return to shareholders at 50%. Look, that's where we are right now. I think I'm going to preempt Geoff a little bit in the sense that I don't want him to talk about this stuff right now. It's too early, and there will be change depending on circumstances.

I think there'll be continuity and change, and then we'll go forward with this game plan. Depending on how things roll out, I'm sure Geoff will make the appropriate decisions. Okay, the second part, I think was Karen's.

Karen Parkhill
EVP and CFO, Medtronic

Yeah. First of all, we have plenty of firepower, and we're going to use it wisely.

Omar Ishrak
CEO and Chairman, Medtronic

Yeah.

Karen Parkhill
EVP and CFO, Medtronic

We're going to use it with discipline, just like we have in the past. In terms of tax rate, all of you know that our tax rate has increased this year, with U.S. tax reform. We will be very focused on driving financial leverage in addition to the operating leverage that we can drive in our business to provide a really strong growing bottom line for our shareholders. Part of that financial leverage is tax. Part of it is interest cost, and you've seen us drive that significantly this year. In terms of tax, we're working on it. There are key things happening around the globe in the tax space, that are headwinds. We're working to manage those headwinds, and we're working to drive it lower where we can. Early on, but we're continuing to work it.

Omar Ishrak
CEO and Chairman, Medtronic

Matt.

Matt Miksic
Analyst, Credit Suisse

Thanks so much. Matt Miksic from Credit Suisse. I could say a few things about how strong the pipeline is and how exciting it is, and it is exciting. I wanted to ask just a question around, one of the questions that I get an awful lot, is whether it's process or discipline or changes underway to address sort of the budget, strat planning, guiding, and communicating part of the business. That, for obvious reasons, is also quite important. Just love to hear how you're thinking about it in the past and how maybe your current and future operations and strat planning processes might be enhanced or different.

Omar Ishrak
CEO and Chairman, Medtronic

Well, let me take a cut at it, and then I'll invite certainly Karen and Geoff, if you'd like to make a few comments on that. Yeah, look, the process that we have is that there's an LRP, which we talk about every two years, and then try to meet what we put out in the LRP. I think, that we're going to stick to. There'll be one in June, and we'll give you an update on that. Currently, what we stated we are executing to, since we stated that strategy, and one that we will continue to deliver on. I think we're getting better at using our breadth in a more systematic way. That's how you're seeing some of these margin improvements. We're getting more granular and focused in our strategies around how do you drive the free cash flow in an appropriate way.

We've gotten better. We're a big company with lots of integration work that we've had to do, but I think all of that is behind us, and we're well on our way to making some of these sort of strategies, the execution of those strategies pretty systematic. Expect from us to gradually increase our growth rate. I mean, that's what we're here to do. That's why the pipeline is there. What that amount will be, well, let's wait and see. Okay, I don't know if you guys want to add anything to that.

Karen Parkhill
EVP and CFO, Medtronic

I'll let Geoff start.

Geoff Martha
President, Medtronic

I'd just reemphasize, the integration from Covidien, it really wasn't integrating Covidien. It was combining two companies. It really was kind of a merger. They had 45,000 people. We had 45,000 people. That's a pretty big undertaking, and I do think the bulk of that work is behind us, and that did take a lot of management bandwidth. That puts us in a better position. I think you're seeing there's still room for improvement on that. We still haven't fully leveraged our breadth in emerging markets, so there's upside to that. I don't want to say, we haven't learned to use our new breadth. It wasn't too long ago that 40% of Medtronic's income came from CR, Cardiac Rhythm. I mean, we're a long way from that.

We still haven't fully realized how to use our breadth, and that's something we're going to work on. A lot of the work is behind us, and we can focus, and we're seeing, and you see it, and I hope you're starting to hear it over the last couple of quarters, the focus on innovation. It's a much deeper focus. I think that and some of the certain emerging markets, that those two focus areas will get the performance.

Karen Parkhill
EVP and CFO, Medtronic

The last thing I would add is that I think we all are very firm believers in continual improvement. As we think about continual improvement, that goes for our processes around long-range planning, around annual planning, around forecasting. As we look at embarking on our long-range planning and strategic planning process, which we do every fall, some of the things that we're really focused on adding this year are things around managing our risks better and retiring risks and building that into the process, along with ensuring that we've got the right investments in place to drive that growth for the future. We're going to be focusing on doing a little bit more of that than we have in the past.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

Larry Biegelsen.

Larry Biegelsen
Analyst, Wells Fargo

Thanks a lot. Larry Biegelsen, Wells Fargo. One for Bob, one for Karen. I'll ask them both upfront. Bob, the FDA is accepting overseas data, so why wouldn't you just file the robot with the CE mark data and get approval in the U.S. one year sooner than the current timeline? Karen, I know it's early, but you guys have alluded to accelerating top-line growth in FY 2021, but you do have about $250 million in hedging gains in FY 2020. My question is, do you see anything today that would prevent you from growing 8% EPS on an 8% reported basis in FY 2021? That hedging gain this year is a pretty big headwind. Thanks for taking the question.

Bob White
President of MITG Business, Medtronic

Let me take the first one.

Karen Parkhill
EVP and CFO, Medtronic

Yep, you go.

Bob White
President of MITG Business, Medtronic

Larry, thanks for the question. We're looking at all ending goals constantly to figure out the appropriate regulatory path to file. Our clinical strategy at this point leads us to ensuring there is both, if you will, not exclusive OUS data or not exclusive U.S. data. As we prepare for those submissions, I think we'll look at everything. Very ongoing discussions with the competent authorities.

Omar Ishrak
CEO and Chairman, Medtronic

Let me just twist in. Bob may or may not agree, but I'm sure he will.

Bob White
President of MITG Business, Medtronic

I don't know.

Omar Ishrak
CEO and Chairman, Medtronic

If there's an opportunity to accelerate, we will accelerate. Okay?

Bob White
President of MITG Business, Medtronic

I can agree with that.

Omar Ishrak
CEO and Chairman, Medtronic

Agree with that.

Karen Parkhill
EVP and CFO, Medtronic

That goes for everything that we do.

Omar Ishrak
CEO and Chairman, Medtronic

We're not holding anything back. If you get a firm sort of line of sight around something like that, we'll put it in place.

Bob White
President of MITG Business, Medtronic

For sure.

Omar Ishrak
CEO and Chairman, Medtronic

It's just too early for us to kind of commit to that right now.

Bob White
President of MITG Business, Medtronic

Yeah.

Omar Ishrak
CEO and Chairman, Medtronic

Okay?

Bob White
President of MITG Business, Medtronic

For sure.

Karen Parkhill
EVP and CFO, Medtronic

On your second question, Larry, we're not giving guidance for next year yet. We are committed to that 8% growth over the long-range plan. We had a headwind this year that we worked hard to try to overcome in the tax rate step-up. I don't see any major headwind for next year at this stage. We've got the medical device tax that could come back looming. That's a potential. Like every headwind, we're going to work hard to overcome it.

Ryan Weispfenning
VP and Head of Investor Relations, Medtronic

All right. We're going to stop there. I want to end the day by thanking all of you for making the trip here to Hartford. Thanks to everyone who joined us online. Thank you to the MITG team and the Medtronic leadership team. I look forward to speaking to you tomorrow from Chicago at NASS. Thanks.

Omar Ishrak
CEO and Chairman, Medtronic

Great. Thank you.

Bob White
President of MITG Business, Medtronic

Thank you.