We're going
to get started everyone. Good afternoon. I'm Ryan Weispfenning, Vice President and Head of Investor Relations at Medtronic. Thanks for joining us for our virtual Cardiac and Vascular Group Investor Briefing to discuss the clinical data that is being released in connection with the 2020 American College of Cardiology together with the World Congress of Cardiology Scientific Sessions. We're pleased that we're able to hold this event, albeit virtually today.
While we're not together in Chicago as originally planned, I do hope everyone is staying safe and our thoughts go out to those that have been affected by the coronavirus. Before we get started, I want to note that we could make some comments that may be considered forward looking statements, and actual actual results might differ materially from those projected in any forward looking statement. Additional information concerning factors that could cause results to differ is contained in our periodic reports and other filings that we make with the SEC, and we do not undertake to update any forward looking statement. I encourage you to go back and read the slide that's displaying right now. The slides we're presenting today are available on our website, investorrelations.
Medtronic.com. Today's webcasted event will last about an hour with presentations followed by a Q and A session, where we will take questions from the sell side analysts who have joined via the WebEx platform. For the Q and A session, I want to reiterate for the sell side analysts that are listening, what was in their invitation. Also, please make sure you've entered the event ID that was in the invitation along with your full name, which will allow us to identify and call on you. If you're on the sell side and would like to ask a question during the Q and A session, please just click the hand symbol that's next to your name and that will identify you to me so that we can open up your line.
Next, I'd like to point out that while Mike Coyle will make some remarks this afternoon on what we're seeing related to COVID-nineteen, I would remind you that we are only about 2 thirds of the way through our fiscal Q4, and we do intend to update you on the impact later in our quarter. Given today's event is primarily focused on our data at ACC, I'd appreciate if you can keep most, if not all of your questions this afternoon focused on the data. Finally, a quick housekeeping item. Given COVID-nineteen, we've made the decision to postpone our institutional investor and analyst meeting, which originally scheduled for June 2nd, and we're going to hold it sometime later this year. As we finalize the details, we'll make sure to communicate them to you.
And with that, I'll now turn the event over to Mike Coyle, Executive Vice President and President of CVG. Mike?
You all know we've been looking forward to the ACC meeting now for many months, given that there was important data flow that was expected to come here and has in fact been released. And we've been quite pleased with the way the virtual sessions have gone off as a good vehicle to get these data into the public and into the hands of our physicians. As Ryan mentioned, we're going to focus most of the discussion today on the data sets specific to our renal renovation and our TAVR businesses. But I'm going to make some high level remarks about the COVID-nineteen status just because I know that's top of mind for everyone. But most of the presentation and then Q and A hopefully will be focused on the ACC data flow.
So joining me after my introductory remarks will be Dave Moeller, who is the Vice President and General Manager of our Coronary and Renal Denervation business, who will cover the off med data for the treatment of uncontrolled hypertension, which we feel definitively answers the question of the role of renal denervation in that patient set. Secondly, Nina, the TAVR presentation will focus on 2 data sets, the low risk bicuspid data, which we are the 1st company to present data on the bicuspid group with low risk, as well as the leaflet immobility subset of our original low risk patient dataset, which will be shown here for the first time as well. And Professor Peter Capitan, who is the Vice President and Chief Medical Officer for our structural heart group will join on those data presentations. And then finally, we'll open it up to panel Q and A. And in that session, I've asked Doctor.
Laura Mori, who is the Medtronic's VP of Clinical Research and Data Analytics to join us as she's intimately familiar with all of the data sets that are going to be in the studies that are going to be presented today. So with that, why don't we switch to just some high level comments around the COVID-nineteen impact. As you know, as Ryan said, we are still 2 thirds of the way through our current quarter. And so there is a very fluid situation taking place changing weekly. But as these infection rates have rolled out at different rates in different parts of the world and different geographies, we have definitely seen an impact on the delaying of procedures, especially elective procedures.
But in the hardest hit areas, we've actually seen it impact virtually all of our procedure categories. Fortunately, in China, we are actually early on, but seeing essentially the stabilization of new patients being identified and that has led our customer base to want to begin to move back to some sense of normalcy. So we have over the last several weeks have seen sequential increases in procedure volumes week over week, which is encouraging, though still well down year over year from where we were a year ago. In Europe, we have not yet, we believe even seen the peak, especially in places like Italy and Spain. There continues to be very significant on procedural volumes across our portfolio.
And of course, in the United States, we are just really beginning to see the front end of that. Up until 2 weeks ago, we had really seen no impact in the United States. Now, especially over the last 2 weeks and last week in particular, we are seeing pockets around the country in hard hit places like New York, Seattle and now increasingly some other cities where we are seeing meaningful procedural slowdown. So as Karen had mentioned on the Q3 call, we do expect there to be material negative impact on our top line for our fiscal Q4, which runs from February to April. And as you know, we are generally a month lagged behind our most of our industry peers.
So we would expect even more impact on our Q4 relative to what will come in the Q1 reports of those in the industry. And I would also point out that there is typically seasonality in the Q4 numbers for Medtronic, where there is more end of quarter activity in our Q4, which we expect will be impacted by the virus situation. Of course, across all of the groups, there is a range of procedures running from highly emergent to highly elective. In our business, we are seeing the product categories such as stents and pacemakers and LVADs be more skewed toward the less elective side or more emergent side. And then areas like our insertable loop recorders, the link as well as our AF ablation procedures to be more in the elective elective category in terms of the impact.
And then between those 2, some of our larger businesses, ICDs and TAVR kind of sit in the middle. And that's similar to the other groups as well. MITG has more emergent procedures in trauma and appendectomy and more elective procedures in things like bariatric surgery. And in RTG, while neurovascular has many emergent procedures, the spine and neuromod businesses tend to skew more toward the elective. There are specific product categories for Medtronic that are being we are seeing significant increases in demand.
And I would point to things like ventilators, pulse oximeters and capnography within MITG as well as ECMO procedures and equipment within CVG. And we are seeing within our diabetes group a move for patients who want to increase their on hand level of supplies. So those are things that actually are showing acceleration versus what we'd have generally expected to see. But as Ryan mentioned, we would expect to provide a more detailed update later in the quarter toward the end of the quarter. And this is just to give you some sense of what we're seeing sort of mid quarter.
The one other thing I would mention is that last week we did decide to basically pause clinical trial enrollments across the portfolio. We do leave it open to the investigator at the site if they want to continue to enroll. But generally speaking, we are essentially freeing up resources from those sites to deal with the emerging crisis. And therefore, we do expect there to be some impact on the timing of some of the clinical trials that we are currently executing on. So that's pretty much all we'll want to cover on COVID-nineteen.
Obviously, if there are additional questions, we would prefer that they be really focused on the clinical data that we're showing here at ACC. So switching to sort of the discussion topics for today, I did want to remind everyone that there are a number of important growth drivers that have been launched into the market in the last couple of quarters or will be in the near term. Obviously, the EVOLU Pro Plus family and the low risk and now bicuspid data being made available on the DCV side or AV access product entry. And this quarter, we have now launched the Micra AV transcatheter pacing system. In addition, our next generation of ICDs, the cobalt and chrome families have now been launched into Europe and will be launched into the United States during the Q1.
We would also expect during the first half of next year to see important new products such as the DiamondTempar fibrillation system and the REVEAL LINK 2.0 entering into the market. But today's discussion is really going to focus on data flow and especially 3 particular clinical studies that carry a lot of interest. The Ardian off med pivotal trial data that Dave Moll will present on and then within the TAVR business, the Evolutelow Risk Bicuspid and B FLT Mobility data. But I would point out there are other important data sets that are also being shown here at ACC. The ONYX-one CLEAR study, which is the we're very excited about, which basically positions us with the positive outcome of the data presented to be the 1st company we believe to be able to get 30 day dual antiplatelet therapy labeling on our On X coronary stent, which is an exciting development within the coronary business.
And then we also presented extended data from the RAPID study on risk stratification for TYRX as well as 3 year confirmatory data on the sustainability of the benefit that that TYRX brings in infection reduction. And of course, if there are questions about it, we can also talk about how MicroAV is going, even though there's no new data at this meeting on that topic. So with that, let me turn it over to Dave Moler and we will begin with the Aardian OFF Med pivotal trial data. Dave?
Great. Thank you, Mike. I'll start by putting the OFF MED trial into perspective. The purpose of the OFF MED trial was to prove definitively that renal denervation works in the most rigorous fashion, a powered randomized, sham controlled trial without drug adherence as a confounder. And we have a broader compendium of clinical data to answer the other questions around durability and the magnitude of effect.
And I should also mention and Mike just mentioned that the OnMed trial enrollment is currently paused in most centers due to COVID-nineteen. The SPIRAL HTN OFF MED pivotal trial proved that Ardian works in the absence of medication at 3 months. So the primary endpoint tells us that Ardian works, full stop. The chart on the right is what you're most accustomed to seeing. I think the baseline blood pressures represent a moderate hypertension population, the baseline of 151 for 24 hour blood pressure and 163 office blood pressure.
The renal denervation arm saw a 4.7 millimeter of mercury drop in systolic blood pressure and 9.2 millimeter mercury drop in office blood pressure. These results are consistent with the data from the OFFMed pilot study. And the magnitude of drop seen in the study is clinically meaningful. In fact, all blood pressure reduction is helpful From a seminal publication in The Lancet with data on a 1000000 people, we learned that even a 2 millimeter drop in office is solid blood pressure results in significant mortality risk reduction. But we also know as discussed in today's Lancet publication that this isn't really the right study to use as a gauge for measuring the magnitude of effect of renal denervation for at least these two reasons.
First is the duration of follow-up. In every Ardian trial, we see a continuing drop in blood pressure well beyond 3 months. And second is just the rigorous nature of this trial. If a patient's blood pressure went above 180 office, they were excluded from the results and were considered escaped. There were not surprisingly significantly more escapes in the sham arm which can cause an understatement of the difference between the two arms in the trial.
Now these charts here demonstrate the impact that renal integration has throughout the entire day. The renal integration arm is the chart on the left and the sham arm is the chart on the right. The gray line is the baseline blood pressure and then the red and blue lines are at 3 months. What this shows is that Reynolds innovation is always on. And this is significant because patients are at greatest risk for cardiovascular events in early morning hours during the morning surge.
And as mentioned in the Lancet publication, medication levels can reach a trough during night and early morning periods due to dosing schedules. So there may be a clinical benefit to the always on aspect of RDM. Finally, I just want to remind you of the rigorous and large real world data set that we have with the global SIMPLICITI Registry now in over 2,800 patients. And this data set helps us understand the durability of effect now with data out to 3 plus years. And it gives us more confidence in the safety profile as well as the consistent effect across patient subgroups.
And this is really compelling high quality data that the FDA is very interested in and really nobody else has this kind of data. So in summary, Ardian works. The magnitude of effect is meaningful, but understated in this study and requires the OnMed study and the global SIMPLICITI registry to really quantify. Renal intravation is always on, which is an important element of a device procedure and our real world data supports the durability and effect the durability of effect and the safety. Finally, you can read now available the publication in the Lancet as it was simultaneously published online.
So let me now just move on and talk about the market opportunity. As you know, hypertension is a massive health and financial burden. It affects a third of adults and is the single largest contributor to death. Now I think it's really important to highlight the magnitude of the non adherence problem. Half of patients are non adherent within a year of initiating therapy.
And this is a situation that Medtronic has been given credit for, for shining a light on by leading society. And in spite of the availability of drugs, 2 thirds of diagnosed patients remain uncontrolled. So I think this really highlights the need for an alternative tool to fight hypertension. So this is how we look at the size of the opportunity. Let me just first say that we will be pursuing broad labeling upon initial approval of Ardian And that's not what this slide represents.
This is a simplified illustration of how we see the addressable market evolving over time. So from a physician perspective, it's likely to start at the left, patients with office blood pressure over 150 and taking lots of men. And it will expand to the exponentially larger pool of patients on fewer men. And then finally, the addressable place the addressable population can again double as it expands to patients with more moderate blood pressure. Just for reference hypertension 3 HTN3 studied a population similar to the smallest circle on the left, but was even smaller as it was patients over 150.
And to give you an idea of the dollars that this represents, a 1% penetration of the middle bucket would represent about $1,000,000,000 market. So we've gained an understanding of the patient segments who are candidates for renal denervation and how to find them. First on the left is the compliance patient who has struggled for years to get her blood pressure under control with many meds and still is in control. These are the patients for whom physicians are seeking an alternative and are willing to refer for renal denervation. Next in the middle is the high risk patient who has high blood pressure combined with multiple comorbidities putting him at an elevated risk for an event like a stroke or an MI.
And finally, the non adherent patient who for any number of reasons doesn't take all of his or her prescribed medication. And this patient is highly motivated to find an alternative. We know this to be true as 80% of the patients in our trials were self referred. Okay. Now I know you're interested in the timing for U.
S. Approval. Our clinical package to the FDA for approval will include the OnMed data and enrollment in that study is currently paused due to COVID-nineteen. Now pre COVID-nineteen, we were on track to complete enrollment in the OnMed study just a couple of months from now. And now, of course, it's more difficult to say exactly when we'll complete that study and file with the FDA.
I'm really happy to share the exciting news that we received breakthrough device designation from the FDA just on Friday. Breakthrough device designation supports an expedited review process by the FDA, but it also improves the likelihood of getting the Medicare add on hospital payments upon approval. And it also provides the possibility of automatic temporary Medicare coverage upon approval. Now regarding reimbursement in the U. S, we're working with CMS, private payers and physician societies for favorable reimbursement.
We're leveraging multiple channels to engage both CMS and private payers to make sure our clinical and our economic evidence meets their needs. Once we have the OnMed data, then we'll be able to publish the updated economic evidence to demonstrate cost effectiveness, which if it's similar to the pilot study should be very positive. So in closing, I'm thrilled to have definitive proof from a powered randomized sham controlled trial that renal denervation works. The market opportunity is exciting, could be a $1,000,000,000 market by 2026. Similar to other therapies, I think the U.
S. Will be almost half of that. Getting to a $1,000,000,000 market will require favorable reimbursement, guidelines and significant market development of both referral channels and direct patient outreach, all of which we know how to do. Significant next steps for us include completing the ONMEND trial, of course, which is a critical path for approval in the U. S.
And enrolling the spiral distal study, which is a clinical trial aimed at demonstrating the feasibility of a much faster procedure to achieve the same results. So now let me pass it over to Nina.
Thanks, Dave. In addition to what we think is very exciting results from our renal renovation trial, we're also excited to share the clinical results presented this morning of both our bicuspid trial, which is the 1st and only data set to be presented in the LOVEST population as well as the leaflet immobility data, which will be the first significant industry published data on LTI in low risk patients. Before we start, I just want to make a few comments about the market and how we're addressing it. As we've stated before, we believe the size of the tavern market is about $5,000,000,000 That's consistent with what we've been talking about growing in the mid teens. Also as we stated before with the NCB expansion, we believe we'll see about 800 accounts in the U.
S. Doing TAVR procedures. And as we've been talking about, we've been aggressively hiring to ensure that we can cover just about all of these accounts. So as we look to the low risk patient population, we believe that about 60% of the low risk patients have a bicuspidal, which makes this first to be presented and published data set so incredibly important for patients. So if we go to the next slide.
I think it's clear as we think about the low risk approval that this is what has really created a significant paradigm shift in terms of device selection in these lower risk and potentially younger patients. With low risk, the criteria for device selection has shifted from really just thinking about risk characterization to moving towards more towards age, towards anatomy and towards activity level. And in this population, it's becoming clearer that hemodynamics patients have faced this mismatch, the ability to treat by custard valve and valve durability becomes much more important. So these are the areas really backed by data that Medtronic is going to be focusing on as we move forward because that's where we think the Evolut platform excels in terms of providing the best valve to patients. You'll see as Professor Kapitan walks through the data set that we've continued to show benefits in mortality, stroke, PBL and the continued trend downward in pacemaker rates.
I'm going to come back to that a little bit later. So that's really why we're so excited to present these 2 datasets, both of which show excellent outcomes for Evolut in low risk patients. So Peter, let me turn that over to you and then I'll come back in a short
while. Thank you very much, Nina. So I'm happy to present these low risk data and especially focusing on bicuspid patients. And bicuspid anatomy is actually the most common congenital malformation, heart malformation. And it results in that more than 60% of patients who are at low risk and who have an aortic stenosis have bicuspid valve.
Acuspid valve is a specific type of valve in the heart disease because it's more complex. The anatomy is more complex, which increase the risk for annular rupture, repair valve leakage, for pacemaker implantation and for stroke. Our cost of patients were actually excluded from LoRa's trials and are therefore understudied up until today. The aim of the Evolut Low Risk Bicuspid study was therefore to assess the safety and efficacy of transcatheter aortic valve replacement in patient with a bicuspid aortic valve stenosis who were at low surgical risk. In this study, 57% of the patients received an Evolut Pro Valve and 43% received an Evolut R valve, of which 98% was aware of the size of 34 millimeters.
And of course, these results of these studies will be submitted to the FDA for a revised target labeling. So that allows us to train people and educate them on how to use the Evolut platform in patients with bicuspid valves. And important to note is that Medtronic is leading the way in low risk bicuspid transcatheter valve replacement by being the 1st and only company today to present their bicuspid data. So important to note is also that here that how similar the results are between bicuspid and trilevel patients despite the increased complexity of treating bicuspid patients. Actually, there was only one patient death and one disabling stroke in the population with microspert valve.
Major vascular complications were very low and there were no cases of annular rupture. Despite being at an increased risk for pacemaker, the pacemaker rate is lower for bicuspid patients in this new study. And we have seen that IP pacemaker rates continued to decline in real world TVTR data at 12.8%. So the encouraging is also that the MEDAS and cost overlap techniques have demonstrated that low single digit pacemaker rates are consistently achievable with Evolut. Now in the Evolut low risk trial, Evolut showed superior hemodynamics versus surgical ABR, which are mirrored here for bicuspid patients.
The effective or obvious areas more than 2 are critical to avoid severe prosthesis patient mismatch, which was observed in only 5% of patients in this study. In the Part III study, SAPIEN showed statistically worse hemodynamics than surgical AVR for the first time in anti TAVR study. In the Part III main cohort, 34% of patients were left at any prosthesis based mismatch with SAPIEN 3. So excellent results here for both bicuspid and trilefin patients. But important is to note that actually there's 0 moderate or severe paravalvalve leakage for patients with a bicuspid anatomy, which actually are more complex and have a more irregular anatomy.
So from this bicuspid study, we can conclude that Medtronic is the 1st and only company to present a low risk bicuspid data. As far as we know, Partners Free has also bicuspid substudy that completed enrollment in June 2018, but we haven't seen the results so far. We believe that these results demonstrate how Evolut should be developed choice for patients with a bicuspid anatomy. And the results of this study will be submitted to the FDA for revised TAVR labeling so that we can train people how to use the AdBlue platform in patients with piquus with anatomy. So now I will transition to the leaflet thrombosis thickening and immobility study.
The leaf the LTI substudy and the Partners V CT substudy were mandated by the FDA following the publication from Doctor. Makar in the New England Journal of Medicine in which he found 40% of leavous thrombosis for the portico valve. A liver thrombosis includes the presence of an hypoattenuated liver thickening, abbreviated as HALT and reduced liver motion, abbreviated as RLM. The aim of this study is purely observational and designed to understand the instance of LTI with Evolut. The images here that you see here on the slide show a thickened leaflet on top and the extent of leaflet restriction of a leaflet on the bottom.
And more than 50% reduction in leaflet motion has been found to be clinically significant. Now while there are still many questions on the impact of leaflets from both us, we know that increased gradients are tied to structural well deterioration. And previous literature, including the PARTNER CCT substudy, showed an increase of gradients for patients with HALT and or restricted leaflet motion. The extent of hemodynamic impairment in presence of significant halt or ARL may differ between supraannular valves and intraannular transcatheter aortic valves. And that of course may have an impact on long term results mainly on durability.
Now the presence of halt and restricted leave in motion was similar between surgery and Evolut. However, vascular aortic valves have significantly less halt of more than 75% at 1 year. Importance, of course, is now to look at the consequences, the clinical consequences. And actually there was no change on hemodynamic performance with the extent of HALT. As you see, the yellow bars are the patients with the TAVR.
And absolute TAVR gradients remain consistently low in the single digit regardless of the presence of Halt. Now what does it mean now if we look at gradients? Well, for context, data on the right is shown from the PARTNER 3 CT substudy posted in their IFU. And important to note is also that the same correlate was used for both the PARTNER study and for our Evolut low risk substudy. Evolut showed that less halt of more than 50% and consistent low single digit gradient.
While it appears that the Sapiens V gradients are impacted by a halt of more than 50% with higher gradients. Now if we look at Evolut, the LTI structure of L deterioration, Evolut shows less RLM of more than 50% and consistent low single digit gradient, while it appears that safety and 3 grades are impacted when they have an RLRN of more than 50%. And I think that it means even the criteria for structural valve dysfunction, which means that valves have a gradient of more than 20 And here I conclude the presentation of the data, and I hand back to Dina Goodhart.
Thanks, Peter. So if you could have been next, perfect. Thanks so much. So as Peter just presented, we believe that the EVOLUTE technology as presented here is well positioned as the valve of choice for low risk patients. And this is really the messaging and the data that we're going to continue to share with physicians going forward.
All of our studies to date continue to show superior hemodynamics compared to surgery and to other valve options, which we think is critical to lower risk and potentially younger patients. These data sets also continue to show as Cedar showed excellent procedural success outcomes in mortality stroke in PBL and we continue to see a downward trend in pacemaker rates. Most of you will recall that in our low risk study, our highest enrolling centers showed single digit pacemaker rates. This has been reinforced by a number of other studies, including the MIDAS study out of NYU, which showed a pacemaker rate of less than 5%. Our OPTIMIZE PRO study is looking at enhanced procedural techniques and pathways, and we believe that consistent single digit pacemaker rates are achievable because we've seen these in multiple centers now in a couple of studies.
Lastly, we have seen very low thrombosis rates across our trials. So these data as well as all of the Evolut evidence in our prior studies gives our teams the ability to reinforce the strong positive benefits of EVOLUDE for all patients, but especially for low risk patients. So I'll end with a quick look at our TAVR pipeline. We've recently launched the Evoloop Pro system with its lower profile and have now put the wrap or the skirt on all valve sizes, including the 34 millimeter valve. Beyond that, we continue to address the needs for patients with our innovative FX system, which will improve the deliverability, the conditioning, accuracy and visualization of our system.
And we also continue to innovate as we focus on life time management, clinical outcomes and procedural efficiencies in our next gen platforms. So with that, Ryan, I think I will turn it over to you to open up
questions from the sell side analysts. And I'd like to remind the sell side analysts who have joined by our WebEx platform to ask a question by clicking on the hand symbol next to your name. As usual, we want to get to as many questions as possible, so please help us by limiting yourself to one question and if necessary a related follow-up. If you have additional questions, please contact me or a
member of my team after the call. And as
I mentioned at the start, I'd appreciate if you can keep most, if not all of your questions this afternoon focused on the data. So with that, we'll pause here for a moment to assemble the queue. Okay. For the first question, let's go to the line of Bob Hopkins. Bob, can you hear us?
Great, thanks. I assume you can hear me, Ryan. Thanks for letting me ask a couple of questions here. Just I'll ask them both right upfront. First of all, can you just give us a sense for the how long it takes from enrollment completion in the Ardian trial to the time you can file with FDA?
And it's sort of a follow-up question. Just want to make sure we understand that gap and how long it will be until you can file once the trial is done enrolling? And then also I was wondering if you could just related to the data today, make a quick comment on how the Ardene effect may actually been understated a little bit given this confidence of safety escape, which I'd like to hear a little bit more detail on that from you guys.
Thank you.
Thanks, Bob. Why don't I just turn that over to Dave Moeller.
Sure. Can you hear me? Yes. Great. So with regards to the first question in terms of timing of completion of enrollment of the OnMed trial and filing, the plan was so if we keep in mind that the OnMed trial has a different endpoint than the OffMed trial is the 6 month endpoint.
So if we once we complete enrollment, which we were planning to have completed just a couple of months from now And then with the 6 month endpoint, the plan was to be able to present these data about a year from now, at which point we could file with the FDA. And so the question now is, okay, how much does that get delayed with the delay in enrollment of COVID-nineteen? But that should give you a good kind of a good ballpark. And then the other question is more color around the understatement of the impact in this trial because of the escape. Is that correct?
Yes, that's exactly right.
Okay. Yes. So what you see and Doctor. Maury could add more. In fact, why don't I just turn it over to Doctor.
Maury to answer that question?
Sure. Thanks, Dave. Yes, great question. So what was the way the trial was designed, there was a mechanism for patients who had blood pressure greater than 180 or patients who had signs clinical signs of problems related to excessive blood pressure to be able to escape from the trial protocol, meaning that their physicians could then prescribe them antihypertensive medication. And what happened is that they were unable to complete the trial endpoint 24 hour blood pressure because of these safety concerns.
That happened almost twice as often in the sham arm. And as a result, those blood pressures that were that would have been elevated were not captured in those sham treat patients. And so that biases the results to be more in favor of the sham arm than otherwise would be. And so the treatment effect measured in the trial is an underestimate of the true biologic effect of renal denervation.
And Bob, I think I would just add one point. Dave announced today that on Friday we received breakthrough device designation from FDA on renal denervation, which is important because it's been our experience that when other therapies such as TAVR, such as Micra, when they are deemed sufficiently differentiated from what else is on the market or available, FDA really has been quite collaborative in terms of compressing timelines. So for Micro AD, for example, the statutory review cycle would have been 6 months. We got it approved in 37 days and within 2 days of having that approval, we also got reimbursement. So I think it's important that if obviously the data has to support that and when we generate the OnMed datasets, but it is encouraging that we have a very collaborative relationship with FDA on this particular technology.
Thank you.
Okay. Thanks, Bob. Let's
go to the line of David Lewis.
Good afternoon. Can you hear me okay?
Yes, we
can. Great. David, just two questions for you. The first is just the net benefit of 4 points. I mean, some clinicians would say that was sort of not clinically meaningful, but they also would say it's going to get better over time.
So with that being said, when can you see the 6 12 month data for off med? And would you expect the net benefit in SDP in on med at the same time periods to be better than what we've seen with off med? And then I just had a quick follow-up on reimbursement.
Okay. Let me make sure I understand the first question. So first of all, the magnitude of drop, 4 millimeters of mercury maybe not being as impressive as some people would like to see. And so when will we see the longer term data for OfMed? I think that's a great question.
We will be bringing that data out soon. We just needed to make sure that we had enough patients in that off med cohort to be able to have a meaningful data set. And so we'll be looking to present and publish that data soon. Let's see. The second question was, should we see a better result for a larger magnitude of effect from the OnMed trial, I believe.
I think there's no reason for us to believe that we won't see something very similar to what we saw in the pilot study. And so what we've seen in every trial, including OnMed is that magnitude of effect continues to progress beyond that 3 month period. And in fact, what we see beyond that in our global simplicity registry, which is a less rigorous that it goes beyond that 6 month period as well. I'm not sure if that covers both of your questions.
That's very, very helpful, Dave. And just a quick follow-up is just your reimbursement strategy long term, very clear in the presentation. Can you give us a sense of the strategy near term on tax reimbursement for de innovation? And do you think that level of reimbursement is going to be significant enough for near term adoption? Thanks so much.
I'm sorry, I have just a little bit of an echo when you're speaking. You're just going to have to repeat that one more time.
Okay. The strategy around reimbursement long term was very clear. Can you give us a sense of the timing to getting long term reimbursement? And then for near term CAT III reimbursement, do you think that's going to be significant enough for broad adoption? Thank you.
Sure. So it's a Category 3. So that's when we're talking about a Category 3 versus a permanent category 1 code that will most certainly take some time, but that's specifically referring to the physician payment. Now one thing I want to make sure is clear to folks is that this patient population that we're studying straddles Medicare and private payers. In fact, what we see in our current studies is that the majority of the patients are actually pre Medicare age.
What we see in a real world setting is that it's closer to fifty-fifty. So we're going to be working both angles at 1. And with regards to the physician payment, which is kind of what you asked about with the Category III code, yes, it is going to take us some time to get a Category 1 code and that just means we're going to have to work directly with the payers to negotiate that payment rate. And it certainly doesn't help, but we think it will be enough for near term adoption.
Thanks, David. Let's go next to the line of Larry Biegelsen. Larry?
Hey, Brian, can you hear me okay?
I can.
Great. Hey, Dave. One for Dave and one for Nina. Dave, with the breakthrough congratulations on the data. And with the breakthrough designation, do you think there's any chance FDA will allow you to file and give you approval without the full OnMed data?
No, I think we're going to need the OnMed data, Larry.
All right. And Nina, can you talk about some of the changes you made since fiscal Q3 to the sales force and otherwise? And any color you could share for your TAVR business? Obviously, in calendar Q4, Edwards did a little better than you guys. Anything you could share on the impact prior to coronavirus and those changes?
Thanks.
Thanks, Larry. I think as Mike Coyle talked about in the last earnings call, it became very clear to us that we were under penetrating the growing number of TAVR accounts and not getting to all of the accounts that we needed to get to. And so really what we've been doing now are a couple of things where as I mentioned before, we're aggressively hiring. Our goal is to be able to cover at least 90% of all TAVR accounts. We've also been working as you see here on our clinical data.
We want to make sure that physicians really understand the benefits of this valve and that they're focused on communicating the benefits of the valve based on the data that we have. So I think you're going to see a my guess is you would have seen a big difference based on what we were seeing in early Q4. Prior to COVID-nineteen, we saw a significant increase in our implant rates, which was which we expected to see given the changes that we made. And I think once we get past COVID-nineteen, we'll continue to see that.
Thank you.
And you may also want to mention, Nina, the hemodynamic advantages and their potential to impact the long term the hemodynamic advantages and their potential to impact the longevity for a superannular design, which is obviously something that we are going to be pushing aggressively into our accounts.
That's exactly right, Mike. Thanks.
Okay. Thanks, Larry. I'll just ask that those that have already had their questions answered, if you can click on your hand again to go out of queue, unless you want to remain in queue and then I'll call on you again. Let's go next to the line of Robbie Marcus. Robbie?
Great. Thanks. I wanted to ask about the bicuspid data. You guys have obviously come up against a little selling pressure versus Edwards in the last quarter. And we haven't seen bicuspid data from Edwards, even though they have it apparently.
So do you think this really good bicuspid data will help you in the marketing advantage once you can get back into hospitals post COVID-nineteen in low risk?
Would you take that, Tina?
Yes. No, I think absolutely it will. I think that there's been a lot of questions about how these valves operate with bicuspid patients given the size of that patient population and there hasn't really been any good data to your point. Our understanding is that Edwards has their bicuspid data completed. We're hoping we'll see it soon, but we haven't seen it yet.
With the data that we just presented here, we think it gives us a significant advantage. So as physicians are making that valve choice, now that they can look at this really positive bicuspid valve data, they can look at the long term immobility data that Peter just went through as we think about valve durability and we think about the really strong hemodynamics that we continue to show in all our trials. Based on our conversations, those are the things that physicians have wanted to understand and see. And I think with our very focused sales messaging now, these are the data that we're going to be taking into account going forward.
And Robbie, I would just add, this data is available for us immediately in Europe to be able to promote on. Obviously, in the United States, we need to work with FDA to get the labeling restrictions listed.
Great. And maybe one quick follow-up. I know you're still going to need OnMed data for renal denervation to get approval. There's a lot of market education that needs to happen between now and 1% penetration or $1,000,000,000 in sales. So what can you start doing again once COVID-nineteen subsides?
What can you do between now and approval to help
Yes. Sure. First thing I would say is we're approved already. It's the benefit of having been at this for so long. We're approved in many parts of the world already.
So a lot of the work that we need to do in the international markets, we can do right away. And so with this kind of stamp of approval that it works, we can go ahead and kick off a lot of that work and start to move the needle. Now in the U. S. And by the way, that work then as soon as we do have the OnMed data, which really is what will move the needle for payers and referrers, then we can immediately see that trajectory pickup as we wait for approval in the United States.
That's more limited obviously in terms of the activities that we can do in the United States. But we will do what we can and we'll be prepared and we're learning through our now getting to be very extensive experience in enrolling clinical trials how to develop that market particularly in that direct to patient efforts. And that's how we've been able to change the trajectory of enrollment in our trials is through some of our direct to patient initiatives. And so I think we have time and we'll be ready.
Thanks a lot. Thanks, Robbie. Let's go next to the line of Vijay Kumar. Vijay?
Hey, guys. Thanks for taking my question. 2 for me. 1 on the RDM data that you guys presented, shared the color on the market opportunity sizing. The $2026,000,000,000 $1,000,000,000 timeline, I'm assuming that that contemplates the delay in filing here.
And we've heard some rumblings around procedure times given the average number of ablations here per patient being in the 40 to 50 range. Is that what can you do to perhaps make this an easier procedure, I guess? Or is that an issue at all?
Yes. Thank you very much for that. Thank you for that question. So let's talk about the $1,000,000,000 market. We're talking about a matter of hopefully a matter of months, a few very few months hopefully in delay with result to this as a result of the COVID-nineteen.
So hopefully that doesn't necessarily change dramatically the timing of when it can become a $1,000,000,000 market. But obviously it's a month for month impact that that would have. So that's the answer to the first question. The second question, and I'm glad you asked that, The procedure time and contrast usage is high in our clinical trial. And that's a result of having a very, very rigorous clinical trial where we're documenting step by step where each generation is taking place and continue to use contrast to visualize at every step of the way.
So in the real world, like in our global SIMPLICITI registry, that procedure time is about half of what you see in the rigorous sham controlled clinical trial. Furthermore, beyond that what we're doing and we have now some good evidence to suggest that we know better now how to target the denervation. And so that's why we've kicked off well, of course, now it's delayed with COVID-nineteen kicking off another study called the spiral distal study, which will aim to show that with a more targeted ablation, it's much fewer ablations and a much faster simpler procedure that we can get the same effect. So first, it's much faster, simpler in the real world and we're working with a trial to get it even faster and simpler. And of course, we're in it for the long run and we'll continue to work also on as we consider technologies.
That's helpful. And Mike, one quick follow-up for you. I think I've shared the comments on China. I understand week on week improvements, but it's still down year on year, what you're seeing in China. Just based on this week on week improvement, at what point do you think China normalizes and we can get back to year on year growth?
Thank you.
Believe me, that's a question I've been asking our team there for the last couple of weeks. Obviously, it's difficult to say given that there is a number of sort of contributors to the return. The centers have to be ready and willing to execute on the procedures. You have basically patients need to be willing to go back into the hospitals and there's still some concern about whether there's going to be a second wave that of infection that basically has patients somewhat reluctant to go into the accounts. So we're encouraged that we're actually seeing the centers wanting to engage in sort of restarting their programs and try to get them back to normal levels.
The patients are going to have to come along with that as well. And it's just we're in uncharted territory that I can tell you. We're looking very carefully at China and at South Korea as the places where we should be able to develop models of how quickly things come back by product category. And it's just too soon. We don't have enough data points to be able to give you anything better right now.
Thanks, Vijay. Let's go to Kristen Stewart. Kristen?
Hey everybody. Hope everyone is well and safe.
I was wondering if you guys could just comment on Edwards to your data and just how you're thinking about marketing that relative to your low risk data as well? And then I have a follow-up.
Why don't you take that, Nina?
Yes. We just saw the data like all of you this morning, so we're in the process of trying to absorb it. I think there are questions about thrombosis. They'll have to dig into that. Really, what we look at is our own data.
So we look at the really low thrombosis rates that we have continued to have across all of our data sets. We look at the LTI data that we presented here and the strong linkage between that and hemodynamics and we look at durability and we look at again the LTI data that we presented here as well as some of the longer term data sets that we've had like the Italian registry, the NOTION trial, which is showing durability of the EVOLUENT technology out to 8, 9 years. And so, I think overall, TAVR continues to show strong data results, which is a positive. When physicians make device selections, these are the things we're going to have to weigh.
Okay. And then I know you were
talking about your HALT data. Is there anything that would explain your the higher rates of, I guess, HALT in your SAVR group relative to what they had in their group? Because it looks like your rates in SAVR were particularly higher than what they were showing in their study?
Maybe Peter you can take that.
Yes, absolutely. Thanks. So it's very difficult to compare one study to the other one. First, because there are still differences in patient characteristics because there are 2 different patient population, although they're both called lower risk, but there will always be differences. The other thing is that we have different definitions in val thrombosis between the two studies.
Evolut has a different definition for val thrombosis compared to partner. So what you can do, you can compare SAVR versus TAVR in each study, but it's hard to compare one outcome from the ABLEND trial to the outcome of the PARTNER study. What we would do see is that in our study, we have consistently lowered fibrosis rate compared to the CIRCOR, while they in the partner study is the other way around.
Okay. So you're saying you can compare within your study, but you can't compare across to
Across the studies, exactly. So we have lower rates compared to surgery. They have higher rates compared to surgery.
And Chris, that's because, as Peter said, the 2 different patient populations and also 2 different definitions for what thrombosis is.
Okay. All right. Thanks very much.
Thanks, Kristen. Let's go next to the line of Matt Miksic. Matt?
Hi. Can you hear me okay?
Yes.
Great. Thanks for letting us to offer the questions and hope everyone is safe and well. So a couple of follow ups, I guess, on some of the questions you've been getting on TAVR. One is for Professor Capitaine. The 60% bicuspid number that's sort of you've offered around in the low risk patients.
If you could maybe provide some color on how many what percentage do you see in CBRS Type 0 or the most sort of extreme, I guess, 2 leaflet congenital bicuspids and to what degree the data here tells you anything about efficacy or anything else in that particular group of patients? And then sort of what opportunity is percentage of total that represents? And I have one follow-up.
Yes. So in our study, 10% of the patients had CFRS class 0 and the rest had CFRS class 1. So that's the breakdown compared to CVRUS classification.
Okay. And so and that and if you were to say x percent of low risk patients have are in the CBRS Class 0 group, what percent would that be, do you suppose?
So the patient with Siebert Class 0 might be a little bit higher in the let's say, for the 60% because they mostly have very heavily calcified valves. And of course, we led it to the discretion of the site whether the patient could be included in the study. And what we do know from the screening data that also Jeff Poplar presented in his presentation, there were some patients excluded because the valve was considered so heavily calcified that ATAVR would have been preferred. But that's just a very small percentage of the total patient population.
Great. And then maybe a follow-up for Mike and Nina, just around you mentioned the micro launch and understanding that's an important product and an important launch. In the U. S. In this environment, how should we be thinking about what that launch could mean and when we would actually start to see some traction given the difficulty in getting reps into hospitals and any in training or volumes in kind of the Pacer segment in the U.
S. At the moment?
Yes, it's a good question. Obviously, we got reimbursement aligned. So we had pretty much a full quarter start with the launch. And frankly, it was going ahead of what we had expected in terms of it over the course of the launch period, even though we were really targeting 300 accounts. We began to see very significant utilization of the product to the point where it was balancing with what we were seeing in the VR segment.
So we're very encouraged by that launch. But as you point out, there are arguments for using it that are even more compelling now with coronavirus and that the complication rates associated with the patient implants when you use a micro versus a conventional dual chamber system are basically cut by 2 thirds based on our clinical evidence that supported its approval. And so in a hospital that's worried about using up ICU beds, that's a pretty compelling argument. But on the other hand, pacemakers that are being put in that can be put off are being put off in some of these areas where there are just really significant demands on the patient or the staff in the hospital. And we also have that same effect I was talking about in China, where patients are reluctant to go in right now unless they really feel like they need to because they don't want to be exposed to other hospital patients who may be positive for the coronavirus.
So basically, we were very pleased with the kinetics of the launch. It was going ahead of our expectations. And we expect as these waves go through, it will point to why this technology should become much more widely used in patients with AV block.
Thanks so much, Mike.
Yes. Thanks, Matt. Let's go next to the line of Josh Jennings. Josh?
Hi. Thanks, Ryan. So can I just ask on renal denervation, just a $1,000,000,000 market opportunity globally?
Can you
help us think about U. S. Versus outside the United States and the percentage of that TAM? And just remind us where your EU or international R and M business is? Are there any countries that have put a reimbursement in place for renal denervation procedures?
Go ahead, Dave. Sure. So with regards to that $1,000,000,000 market potential, we see this playing out similar to other new therapies and the way they grow, the way we have it modeled. So by the time it's $1,000,000,000 market sometime around that 2026 time period, assuming things go in the right way with regards to reimbursement guidelines etcetera that the U. S.
Would be less than nearly half of that market. Now the way it's going to start will be different because we think we'll get the uptick earlier as we wait for U. S. Approval, especially after we have the OnMed data. And with regards to those international markets, you asked about reimbursement.
The way we see this playing out, today there's very limited favorable reimbursement for renal innovation in international markets. There's a handful of countries where it has favorable reimbursement. Most of those markets are really waiting for that more clinically relevant population with the unmet data. And so it is going to the trajectory increase will really increase more so from that unmet data. Once we have that data, then we see the uptick more in those international markets.
And then obviously, the bigger trajectory impacts globally once we get U. S. Approval. Hope that
helps. That's great. And then just one follow-up on low risk bicuspid data. After CAPIT10, if you just remind us, you mentioned that Edwards finished their enrollment in the registry, I think, in midyear 2018. Can you remind us when Medtronic initially low risk bicuspid registry enrollment when we could potentially see 1 year data?
And then is 1 year data essential for that precaution in the low risk label for Vyaches patients essential to be removed? Thanks a lot.
Yes. No, it's a great question. So I think it's the 1 year data is extremely important because what you would expect is that the complication would occur around the procedure. And one of the procedures that physicians fear most is, for example, annular rupture. And what we have shown is that in our data from the 150 patient that was 0.
And we know that with the balloon expandable valve, where you push the calcium, let's say, towards the annulus and especially when it's asymmetric calcification that the chance of annular rupture is higher. And so I think that's a major advantage of the self explanatory health. And so we hope that, of course, that also that we will see the adverse data. There has to be some speculation that they may present in the TCT, but we're still wondering why it's so late because we think it's an important patient population in the low risk for low risk patients. So therefore, yes, that is, I think, very important.
So I think what we also want to do, we will follow those patients for 10 year. So we also know what the impact is on valve durability. But I do believe that especially we're now concerned and we were concerned about what is the short term outcome for a patient with bicuspid valves. And we have shown now that that's very similar to trileafids.
Great. Thanks, Josh.
I know we've gone over the top of the hour, but there are a few more questions here. So we'll try to get to a few more. Let's go to Danielle Antalffy. Danielle?
Yes. Hi. Good morning. Hello?
Yes. Good to hear you. Okay.
Sorry about that. It's my first time actually using this WebEx thing. So just two questions on renal denervation. I'll ask them together because they sort of go hand in hand. So one of the things I noticed in the comments during the pre submission is physicians asking the question if there was a subset of patients that had a more significant benefit greater than the average that was seen in the trial.
And I'm asking that question as it relates to, are you going to take a look at certain subsets of patients? And I'm curious what's informing the $1,000,000,000 market opportunity by fiscal 2026, because obviously there's tons of patients out there. So what sort of patient is going into that $1,000,000,000 market opportunity number. How are you guys thinking about that in the early days of approval here? And what patients will this be most applicable to?
And that's all for me. Thanks.
Go ahead, Dave.
Sure. Maybe we should maybe Doctor. Maury could respond to that first question about the subset where you might see a more significant response?
Yes, of course. And then I'll throw it back to you, Jason, second part of the question. But for the first part, well, within the OXMAN study, as you know, even though it's a pivotal study larger than the pilot study, it's still relatively small for looking at subgroups. But we don't really see any particular pattern of one group that benefits over another. That being said, we know from the large body of evidence for renal motivation, the higher the starting blood pressure, the more the magnitude of the response is.
And so that fits, I think, with what many physicians will initially feel most comfortable with, meaning that patients with more pronounced hypertension will be the type of patients that they won't think of for this treatment because they'll probably have a higher magnitude of effect. That being said, as Dave mentioned, one of the important observations with the OPDIVATE was the large population of self insured patients, which is really something that we learned through the process of screening for the trial that there is a strong demand for replacement of medications or avoidance of medications in that group of patients who either can't tolerate or are not adherent to therapy.
And then maybe just to answer the second half of your question about how do we think about this $1,000,000,000 market potential by 2026 around that timeframe. The patients the way we think about it and I showed a slide just in terms of how we think about these the patients who are good candidates. And so I'll just reiterate, I think where it starts is similar to what you saw with where we started with HDN3 frankly, where physicians are going to be most likely to refer patients initially are the patients where they're just they just can't get it under control, they're prescribing lots of medication and they still have very severe hypertension. I think that's where it starts. But that also happens to be the smallest of the pools of patients.
And then but there's a lot of interest both by physicians and patients and payers in those higher risk patients. So these are the patients that have lots of comorbidity. They're more risk and payers are interested in them because it's more likely that they're going to have an event in the near future. And then finally, and this is a really important patient pool is the non adherent patient. And don't underestimate how important this is.
Even patients who are younger, who
are being newly who are younger, who are being newly prescribed medication and they're facing a potential lifelong polypharmaceutical approach to managing their hypertension. And what we're seeing in our trials, including in our OFF Med trial with the vast majority of the patients that we're getting are that is that type of patient who says I just don't want to do that. And so they're self referring for this. And so those are kind of the main patient groups that we're looking at. And how we get to that $1,000,000,000 market is kind of a combination and the same what you guys model.
You look at top down in terms of what the penetration is for 4 therapies, particularly a therapy like this where the standard of care is actually pharmaceuticals instead of surgery. And so we can look at similar therapies and over time how quickly they penetrate and then bottoms up in terms of the number of labs, number of patients and we kind of triangulate our numbers that way. I hope that helps.
Very helpful. Thanks.
Thanks, Daniel. Let's go next to Chris Pasquale. Chris?
Thanks. Can you hear me?
Yes.
Okay. One for either Nina or Peter and then one for David. Peter, in the discussion of the bicuspid data set this morning, there was a lot of talk about the need for a randomized trial between TAVR and TAVR in bicuspid patients. Given how important this patient subset is, is that something you guys plan to do? And I'm wondering, given your comments about the potential superiority of EVOLU, would you make it a 3 arm study where you can actually have other commercially available TAVR arms there and try and show that difference?
Yes. It's a good point. And there's a lot of discussion about whether a randomized study should take place. But I think the major concern that a lot of people have is whether you would be it would be feasible to enroll patients. There's a high demand from patients getting a less invasive treatment, so they prefer to have a TAVR treatment.
Then there are a lot of patients that have comorbidities, so they're discussed with the heart team. And whether the patient should is not better off with the fact that within the trial. So it is a lot of description about that topic. And we know that the FDA wants to convene a meeting to discuss this. And actually, there was something planned with industry involvement as well as physicians and societies.
But whether that will still take place due to the COVID-nineteen, probably there'll be a virtual meeting to discuss this. But the major concern, as I just said, is the feasibility of the trial, whether you could enroll enough patients in the So we have to wait and see what comes out of that meeting. But what we have seen now currently with our data set, we're pretty confident that this data set is so good that our bicuspid valve will perform as good as in bicuspidulation as with Pralife patients.
That's helpful. And then David, just following up on the magnitude benefit question. You talked about what a reduction in blood pressure should mean for the prognosis of these patients. How important is actually showing that clinical benefit improving that point to payers? And do you have any plans to try and show that in a subsequent study?
It seems like these studies are probably not going to be the best template to try and look at something like that.
Yes. So to make sure I clarify the question, you're asking, do we think we might need a hard endpoint trial to convince either referrers or payers of the efficacy of reinvigoration. Is that Yes. That's what you're asking. Yes.
I think and Doctor. Maury can certainly weigh in as well. But certainly in our conversations both with the FDA and with payers, it's clear that hypertension is a pretty extensively study you see and just blood pressure for hard endpoints is one of the best established surrogate. And so it seems that both from payers and the FDA, they're going to accept just blood pressure as a surrogate as they've done for medication trials and approvals.
Yes. I agree completely that antihypertensives are evaluated on the basis of blood pressure reduction because we know that blood pressure reductions are associated
with reductions in clinical endpoint.
And then for renal penetration, you have the added impact of the known adverse effects that have non adherence to medications and the effects that has
on cost.
So I think those are the lines of evidence to support that coverage.
And you may want to comment, the data that Dave showed on the 2 millimeter of mercury decrease leading to a 10% reduction in mortality stroke mortality and 7% reduction in ischemic heart disease mortality. These are huge meta analyses done over very large patient sets and there seems to be a view of that being in diffutable that it's that linkage is there.
Yes, that's right. I mean, because there's so many randomized trials comparing antihypertensive agents, There's just a strong body of evidence for the link between blood pressure as an endpoint and clinical endpoints and that continuous the continuous nature of that effect, meaning that there's a graded response to reducing stroke and cardiovascular mortality.
Okay. Thanks, Chris. We'll take one more question. Let's go to Kayla Crum.
Kayla? Hi, guys. Thanks so much for hosting this call and appreciate you taking our question. I'll just stick to one given the time. So on RDM and specifically on Med, just given that enrollment is paused, what are you guys doing to ensure that things to label the track down follow-up patients in this interim period?
And do you think that FDA will be more flexible on patient retention rates in clinical studies during this time? Just curious if you guys have gotten any direct feedback from them on that. Thank you.
Maybe Laura, if you could comment on that.
Sure. Yes, FDA and other regulators have been very active at providing guidance. And just like for us, from our perspective, the most important thing is preserving the safety of patients in studies as well as the hospital staff, etcetera. And so they have indicated that they will have more flexibility in terms of using remote methods for follow-up. So their goal really is for us to preserve the integrity of the trials, while also making it feasible to preserve safety of patients who are enrolled in studies.
And so we'll work we'll be working closely and we have been working closely with the sites to do whatever we can within that framework. Great. Thank you.
Thanks, Kayla. So I think we'll stop there. We'll conclude today's call. We want to thank everyone for joining us today. Thanks for your questions.
If you have any follow-up questions, please reach out to me or a member of my team. The slides and a replay of this call will be available on our website, investorrelations. Medtronic.com later today. So thank you for your continued support and interest in Medtronic and please everyone stay safe out there. Thanks everyone.