Okay, 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. Actual results might differ materially from those projected in any forward-looking statement.
Additional information concerning factors that could cause actual 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&A session where we will take questions from the sell-side analysts who have joined via the WebEx platform. For the Q&A session, I want to reiterate for the sell-side analysts that are listening, what was in their invitation. If you intend to ask a live question this afternoon, please make sure you're connected to the WebEx platform via the new link in the updated invitation you received from Tracy McCartney on Thursday.
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&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-19, I would remind you that we are only about 2/3 Of the way through our fiscal fourth quarter, 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-19, we've made the decision to postpone our institutional investor and analyst meeting, which was originally scheduled for June 2nd, we're going to hold it sometime later this year. As we finalize the details, we'll make sure to communicate them to you. 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. 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 denervation and our TAVR businesses. I'm going to make some high-level remarks about the COVID-19 status just because I know that's top of mind for everyone. Most of the presentation and then the Q&A hopefully will be focused on the ACC data flow.
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 two data sets, the low-risk bicuspid data, which we are the first company to present data on the bicuspid group with low risk, as well as the leaflet immobility subset of our original low-risk patient data set, which will be shown here for the first time as well. Professor Pieter Kappetein, who is the Vice President and Chief Medical Officer for our structural heart group, will join on those data presentations. Finally, we'll open it up to panel Q&A.
In that session, I've asked Dr. Laura Mauri, who is 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. With that, why don't we switch to just some high-level comments around the COVID-19 impact. As you know, as Ryan said, we are still 2/3 of the way through our current quarter, and so there is a very fluid situation taking place, changing weekly. 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. 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. We have, over the last several weeks, 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 impact on procedural volumes across our portfolio. Of course, in the U.S., we are just really beginning to see the front end of that. Up until two weeks ago, we had really seen no impact in the U.S.
Now, especially over the last two weeks and last week in particular, we're 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. 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. As you know, we are generally a month lagged behind most of our industry peers. We would expect even more impact in our Q4 relative to what will come in the Q1 reports of those in the industry.
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 fourth quarter, 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. Then areas like our insertable loop recorders, the LINQ, as well as our AF ablation procedures, to be more in the elective category in terms of the impact. Then between those two, some of our larger businesses, ICDs and TAVR, kind of sit in the middle. 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. 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 seeing significant increases in demand. I would point to things like ventilators, pulse oximeters, and capnography within MITG, as well as ECMO procedures and equipment within CVG. We are seeing within our diabetes group, a move for patients who want to increase their on-hand level of supplies. Those are things that actually are showing acceleration versus what we'd have generally expected to see. As Ryan mentioned, we would expect to provide a more detailed update later in the quarter toward the end of the quarter.
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 that open to the investigator at the site if they want to continue to enroll. Generally speaking, we're essentially freeing up resources from those sites to deal with the emerging crisis. Therefore, we do expect there to be some impact on the timing of some of the clinical trials that we are currently executing on. That's pretty much all we'll want to cover on COVID-19. 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.
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 Evolut PRO+ family and the low-risk and now bicuspid data being made available on the DCV side, our AV Access product entry. 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 U.S. during the first quarter. We would also expect during the first half of next year to see important new products such as the DiamondTemp Ablation system and the LINQ 2.0 entering into the market.
Today's discussion is really going to focus on data flow and especially three particular clinical studies that carry a lot of interest. The Ardian OFF-MED pivotal trial data that Dave Moeller will present on, and then within the TAVR business, the Evolut Low Risk Bicuspid and leaflet immobility data. I would point out there are other important data sets that are also being shown here at ACC, the Onyx ONE Clear study, which we're very excited about, which basically positions us with the positive outcome of the data presented to be the first company we believe to be able to get 30-day dual antiplatelet therapy labeling on our Onyx coronary stent, which is an exciting development within the coronary business.
We also presented extended data from the WRAP-IT study on risk stratification for TYRX, as well as three-year confirmatory data on the sustainability of the benefit that TYRX brings in infection reduction. Of course, if there are questions about it, we can also talk about how Micra AV is going, even though there's no new data at this meeting on that topic. With that, let me turn it over to Dave Moeller, and we will begin with the Ardian 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. We have a broader compendium of clinical data to answer the other questions around durability and the magnitude of effect. I should also mention, Mike just mentioned, that the ON-MED trial enrollment is currently paused in most centers due to COVID-19. The SPYRAL HTN-OFF MED Pivotal trial proved that Ardian works in the absence of medication at three months. 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 mm of mercury drop in systolic blood pressure and 9.2 mm mercury drop in office blood pressure. These results are consistent with the data from the OFF-MED pilot study. 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 million people, we learned that even a 2-mm drop in office systolic blood pressure results in significant mortality risk reduction. We also know, as discussed in today's The 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 three months. 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. These charts here demonstrate the impact that renal denervation has throughout the entire day. The renal denervation 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 three months. What this shows is that renal denervation is always on.
This is significant because patients are at greatest risk for cardiovascular events in the early morning hours during the morning surge. As mentioned in The Lancet publication, medication levels can reach a trough during night and early morning periods due to dosing schedules. There may be a clinical benefit to the always-on aspect of Ardian. Finally, I just want to remind you of the rigorous and large real-world data set that we have with the global SYMPLICITY registry, now in over 2,800 patients. This data set helps us understand the durability of effect now with data out to 3+ years, and it gives us more confidence in the safety profile, as well as the consistent effect across patient subgroups. This is really compelling, high-quality data that the FDA is very interested in, and really nobody else has this kind of data.
In summary, Ardian works. The magnitude of effect is meaningful but understated in this study and requires the ON-MED study and the global SYMPLICITY registry to really quantify. Renal denervation is always on, which is an important element of a device procedure, and our real-world data support the durability of effect and the safety. Finally, you can read, now available, the publication in The Lancet, as it was simultaneously published online. 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 1/3 of adults and is the single largest contributor to death. 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. This is a situation that Medtronic has been given credit for shining a light on by leading society. In spite of the availability of drugs, 2/3 of diagnosed patients remain uncontrolled. I think this really highlights the need for an alternative tool to fight hypertension. 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. That's not what this slide represents. This is a simplified illustration of how we see the addressable market evolving over time. From a physician perspective, it's likely to start at the left, patients with office blood pressure over 150 and taking lots of meds. It will expand to the exponentially larger pool of patients on fewer meds.
Finally, the addressable population can again double as it expands to patients with more moderate blood pressure. Just for reference, Hypertension 3 HTN-3, studied a population similar to the smallest circle on the left, but was even smaller as it was patients over 160. To give you an idea of the dollars that this represents, a 1% penetration of the middle bucket would represent about a billion-dollar market. 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 compliant 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.
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. Finally, the non-adherent patient, who for any number of reasons, doesn't take all of his or her prescribed medication. 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. I know you're interested in the timing for U.S. approval. Our clinical package to the FDA for approval will include the ON-MED data, and enrollment in that study is currently paused due to COVID-19. Pre-COVID-19, we were on track to complete enrollment in the ON-MED study just a couple of months from now.
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. 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. 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 ON-MED data, 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. 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 billion-dollar market by 2026, similar to other therapies. I think the U.S. will be almost half of that. Getting to a billion-dollar market will require favorable reimbursement guidelines and significant market development of both referral channels and direct-to-patient outreach, all of which we know how to do.
Significant next steps for us include completing the ON-MED trial, of course, which is the critical path for approval in the U.S., and enrolling the SPYRAL DYSTAL study, which is a clinical trial aimed at demonstrating the feasibility of a much faster procedure to achieve the same results. Now let me pass it over to Nina.
Thanks, Dave. In addition to what we think is very exciting results from our renal denervation trial, we are also excited to share the clinical results presented this morning of both our bicuspid trial, which is the first and only data set to be presented in the low-risk 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 are addressing it. As we have stated before, we believe the size of the TAVR market is about $5 billion. That is consistent with what we have been talking about growing in the mid-teens. As we stated before, with the NCD expansion, we believe we will see about 800 accounts in the U.S. doing TAVR procedures.
As we've been talking about, we've been aggressively hiring to ensure that we can cover just about all of these accounts. As we look to the low-risk patient population, we believe that about 60% of the low-risk patients have a bicuspid valve, which makes this first to be presented and published data set so incredibly important for patients. 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 more towards age, towards anatomy, and towards activity level.
In this population, it's becoming clearer that hemodynamics, patient-prosthesis mismatch, the ability to treat bicuspid valves, and valve durability becomes much more important. These are the areas really backed by data that Medtronic's 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 for patients. You'll see as Professor Kappetein walks through the data sets that we've continued to show benefits in mortality, stroke, PVL, and a continued trend downward in pacemaker rates. I'm going to come back to that a little bit later. That's really why we're so excited to present these two data sets, both of which show excellent outcomes for Evolut in low-risk patients. Pieter, let me turn that over to you, and then I'll come back in a short while.
Thank you very much, Nina. I'm happy to present these low-risk data, and especially focusing on bicuspid patients. The bicuspid anatomy is actually the most common congenital malformation, heart malformation. It results in that more than 60% of patients who are at low risk and who have an aortic stenosis have a bicuspid valve. A bicuspid valve is a specific type of valvular heart disease because it's more complex. The anatomy is more complex, which increase the risk for annular rupture, for paravalvular leakage, for pacemaker implantation, and for stroke. Bicuspid patients were actually excluded from low-risk 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 patients 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% were of the size of 34 mm.
Of course, these results of this study will be submitted to the FDA for a revised TAVR labeling. That allows us train people and educate them on how to use the Evolut platform in patient with bicuspid valves. Important to note is that Medtronic is leading the way in low-risk bicuspid transcatheter aortic valve replacements by being the first and only company today to present their bicuspid data. Important to note is also here that how similar the results are between bicuspid and tri- leaflet patients, despite the increased complexity of treating bicuspid patients. Actually, there was only one patient death and one disabling stroke in the population with bicuspid 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.
We have seen that actually pacemaker rates continued to decline in real world TVT R data at 12.8%. Encouraging also that the MIDAS and cusp overlap techniques have demonstrated that low single-digit pacemaker rates are consistently achievable with Evolut. In the Evolut Low Risk trial, Evolut shows superior hemodynamics versus surgical AVR, which are mirrored here for bicuspid patients. The effective orifice areas, more than two are critical to avoid severe prosthesis-patient mismatch, which was observed in only 5% of patients in this study. In the PARTNER 3 study, SAPIEN showed statistically worse hemodynamics than surgical AVR for the first time in any TAVR study. In the PARTNER 3 main cohort, 34% of patients were left at any prosthesis-based mismatch with SAPIEN 3. Excellent results here for both bicuspid and tri-leaflet patients.
Important is to note that actually there's zero moderate or severe paravalvular leaks for patients with a bicuspid anatomy, which actually are more complex and have a more irregular anatomy. From this bicuspid study, we can conclude that Medtronic is the first and only company to present a low-risk bicuspid data. As far as we know, PARTNER 3 has also bicuspid sub-study that completed the enrollment in June 2018, but we have not seen the results so far. We believe that these results demonstrate how Evolut should be the valve of choice for patients with a bicuspid anatomy. 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 Evolut platform in patient with bicuspid anatomy. Now I will transition to the Leaflet Thrombosis, Thickening, and Immobility Study.
The LTI sub-study and the PARTNER 3 CT sub-study were mandated by the FDA following the publication from Dr. Makkar in The New England Journal of Medicine, in which he found 40% of leaflet thrombosis for the Portico valve. A leaflet thrombosis includes the presence of an hypoattenuated leaflet thickening, abbreviated as HALT, and reduced leaflet motion, abbreviated as RLM. The aim of this sub-study is purely observational and designed to understand the incidence 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. 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 thrombosis, we know that increased gradients are tied to structural valve deterioration.
Previous literature, including the PARTNER 3 CT sub-study, show the increase of gradients for patients with HALTs and/or restricted leaflet motion. The extent of hemodynamic impairment in the presence of significant HALT or RLM may differ between super- annular valves and intra-annular transcatheter aortic valves. That, of course, may have an impact on long-term results, mainly on durability. Now, the presence of HALT and restricted leaflet motion was similar between surgery and Evolut. However, transcatheter aortic valves have significant less HALT of more than 75% at one year. Important, of course, is now to look at the clinical consequences. 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. Evolut TAVR gradients remain consistently low in the single- digit regardless of the presence of HALT.
What does it mean now if we look at gradients? For context, data on the right is shown from the PARTNER 3 CT sub-study posted in their IFU. Important to note is also that the same core lab was used for both the PARTNER study and for our Evolut low-risk sub-study. Evolut showed that less HALT of more than 50% and consistent low single-digit gradient. While it appears that the SAPIEN 3 gradients are impacted by a HALT of more than 50% with higher gradients. If we look at Evolut, the LTI structural valve deterioration. Evolut shows less RLM of more than 50% and consistent low single-digit gradient. While it appears that SAPIEN 3 gradients are impacted when they have an RLM of more than 50%.
I think that it meets even the criteria for structural valve dysfunction, which means that those valves have gradients of more than 20 mm of mercury. Hereby I conclude the presentation of the data, and I hand back to Nina Goodheart.
Thanks, Pieter. Perfect. Thanks so much. As Pieter just presented, we believe that the Evolut technology as presented here is well-positioned as the valve of choice for low-risk patients. 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 for lower risk and potentially younger patients. These data sets also continue to show, as Pieter showed, excellent procedural success outcomes and mortality stroke in PVL, 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. 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. 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 Evolut for all patients, but especially for low-risk patients. I'll end with a quick look at our TAVR pipeline. We've recently launched the Evolut PRO system with its lower profile and have now put the wrap or the skirt on all valve sizes, including the 34 mm valve.
Beyond that, we continue to address the needs for patients with our innovative FX system, which will improve the deliverability, the positioning accuracy, and visualization of our system. We also continue to innovate as we focus on lifetime management, clinical outcomes, and procedural efficiencies in our next-gen platforms. With that, Ryan, I think I will turn it over to you to open up the Q&A.
Yes. Great. Thanks, Nina. We will now open the event to questions from the sell-side analysts. I'd like to remind the sell-side analysts who have joined via our WebEx platform to ask a question by clicking on the hand symbol next to your name. If you want to ask a question, click on the hand, that'll let us know that you've got a question, then we'll call on you by name and unmute your line. As usual, we want to get to as many questions as possible, 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. 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.
With that, we'll pause here for a moment to assemble the queue. For the first question, let's go to the line of Bob Hopkins. Bob, can you hear us?
Great. Thanks. Assume you can hear me, Ryan. Thanks for letting me ask you a couple of questions here. Just I'll ask them both right up front. First of all, can you just give us a sense for how long it takes from enrollment completion in the Ardian trial to the time you can file with FDA? It's sort of a follow-up question. Just want to make sure we understand that gap and how long it'll be till you can file once the trial is done enrolling. Also, I was wondering if you could just, related to the data today, make a quick comment on how the Ardian effect may actually have been understated a little bit given this concept of safety escape. Would just 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?
Yep.
Yes.
Great. With regard to the first question in terms of timing of completion of enrollment of the ON-MED trial and filing. The plan was, if we keep in mind that the ON-MED trial has a different endpoint than the OFF-MED trial, it's a six-month endpoint. Once we complete enrollment, which we were planning to have completed just a couple of months from now, then with a six-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. The question now is, okay, how much does that get delayed with the delay in enrollment of COVID-19? That should give you kind of a good ballpark. The other question is more color around the understatement of the impact in this trial because of the escape. Is that correct?
Yep, that's exactly right.
Okay. Yeah. What you see, and Dr. Mauri could add more. In fact, why don't I just turn it over to Dr. Mauri to answer that question?
Sure. Thanks, Dave. Yeah, great question. The way the trial was designed, there was a mechanism for patients who had blood pressure greater than 180 or patients who had clinical signs of problems related to excessive blood pressure.
To be able to escape from the trial protocol, meaning that their physician could then prescribe them antihypertensive medication. 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. As a result, those blood pressures that would've been elevated were not captured in those sham treatment patients. That biases the result to be more in favor of the sham arm than it otherwise would be. The treatment effect measured in the trial is an underestimate of the true biologic effect of renal denervation.
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. For Micra AV, for example, the statutory review cycle would've been six months. We got it approved in 37 days, and within two days of having that approval, we also got reimbursement. I think it's important that, obviously the data has to support that and when we generate the ON-MED data sets, but it is encouraging that we have a very good 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?
Yep, we can.
Oh, great. Dave, just two questions for you. The first is just the net benefit of four points. Some clinicians would say that was sort of not clinically meaningful, but they also would say it's going to get better over time. With that being said, when can we see the six and 12-month data for OFF-MED, and would you expect the net benefit in SBP in ON-MED at the same time periods to be better than what we've seen with OFF-MED? I just had a quick follow-up on reimbursement.
Okay. Let me make sure I understand the first question. First of all, the magnitude of drop, 4 mm of mercury, maybe not being as impressive as some people would like to see. When will we see the longer-term data for OFF-MED? 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. We'll be looking to present and publish that data soon. Let's see. The second question was, should we see a better result or a larger magnitude of effect from the ON-MED 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.
What we've seen in every trial, including ON-MED, is that that magnitude of effect continues to progress beyond that three-month period. In fact, what we see beyond that in our global SYMPLICITY registry, which is less rigorous, that it goes beyond that six-month period as well. I'm not sure if that covered both of your questions.
No, that's very helpful, Dave. Just a quick follow-up is your reimbursement strategy long-term, very clear in the presentation. Can you give us a sense of the strategy near term on category three reimbursement for denervation, 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? For near-term Cat III reimbursement, do you think that's going to be significant enough for broad adoption? Thank you.
Sure. It's a category III. That's when we're talking about a category III code versus a permanent category I 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 50/50. We're going to be working both angles at once.
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 I code. That just means we're going to have to work directly with the payers to negotiate that payment rate. It certainly doesn't help, but we think it'll be enough for near-term adoption.
All right. Thanks, David. Let's go next to the line of Larry Biegelsen. Larry?
Hey, Ryan, 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. With the Breakthrough Designation, do you think there's any chance FDA will allow you to file and give you approval without the full OFF-MED data?
No, I think we're going to need the ON-MED data, Larry.
All right. 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. 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.
My guess is you would have seen a big difference based on what we were seeing in early Q4. Prior to COVID-19, we saw a significant increase in our implant rates, which we expected to see given the changes that we made. I think once we get past COVID-19, we'll continue to see that.
Thank you.
You may also want to mention, Nina, obviously, the data flow coming out of this meeting, we think will be very helpful in really providing strong support for the hemodynamic advantages and their potential to impact the longevity for a supra-annular 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, then I'll call on you again. Let's go next to the line of Robbie Marcus. Robbie?
Great, thanks. Wanted to ask about the bicuspid data. You guys have obviously come up against a little selling pressure versus Edwards in the last quarter. We haven't seen bicuspid data from Edwards, even though they have it apparently. Do you think this really good bicuspid data will help you in the marketing advantage once you can get back into hospitals post COVID-19 in low risk?
Why don't you take that, Nina?
Yeah. 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. 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 Pieter 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 accounts going forward.
Robbie, I would just add, this data is available for us immediately to Europe to be able to promote on. Obviously, in the United States, we need to work with FDA to get the labeling restrictions lifted.
Great. Maybe one quick follow-up. I know you're still going to need ON-MED data for renal denervation to get approval. There's a lot of market education that needs to happen between now and 1% penetration or a billion in sales. What can you start doing, again, once COVID-19 subsides? What can you do between now and approval to help educate the market and prepare for a successful launch? Thanks.
Why don't you take that, Dave?
Yeah. Sure. First thing I would say is we're approved already. The benefit of having been at this for so long, we're approved in many parts of the world already. A lot of the work that we need to do in the international markets, we can do right away. 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 ON-MED data, which really is what will move the needle for payers and referrers, then we can immediately see that trajectory pick up as we wait for approval in the United States.
Now it's more limited, obviously, in terms of the activities that we can do in the U.S., 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. That's how we've been able to change the trajectory of enrollment in our trials is through some of our direct patient initiatives. 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. Two for me. One on the RDN data, the two of you vice presidents shared the color on the market opportunity sizing. The 2026 $1 billion timeline, I'm assuming 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 40-50 range. What can you do to perhaps make this an easier procedure, I guess? Is that an issue at all?
Yeah. Thank you very much for that. Thank you for that question. Let's talk about the billion-dollar market. We're talking about hopefully a matter of months, a very few months, hopefully, in delay as a result of the COVID-19. Hopefully that doesn't necessarily change dramatically the timing of when it can become a billion-dollar market. Obviously, it's a month-per-month impact that would have. That's the answer to the first question. The second question, 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 rigorous clinical trial where we're documenting step by step where each denervation is taking place and continue to use contrast to visualize at every step of the way.
In the real world, like in our global SYMPLICITY 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. That's why we've kicked off, well, of course, now it's delayed with COVID-19, but kicking off another study called the SPYRAL DYSTAL Study, which will aim to show that with a more targeted ablation, with much fewer ablations and a much faster, simpler procedure, that we can get the same effect. First, it's much faster, simpler in the real world, and we're working with a trial to get it even faster and simpler. Of course, we're in it for the long run, and we'll continue to work also as we consider technologies.
That's helpful. Mike, one quick follow-up for you. I think Afshin had 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, Vijay, 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 contributors to the return. The centers have to be ready and willing to execute on the procedures. Patients need to be willing to go back into the hospitals, there's still some concern about whether there's going to be a second wave of infection that basically has patients somewhat reluctant to go into the accounts. We're encouraged that we're actually seeing the centers wanting to engage in sort of restarting their programs and trying to get them back to normal levels. The patients are going to have to come along with that as well. It's just we're in uncharted territory.
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. It's just too soon. We don't have enough data points to be able to give you anything better right now.
Thanks, guys.
Thanks, Vijay. Let's go to Kristen Stewart. Kristen?
Hey, everybody. Hope everyone's well and safe. I was wondering if you guys could just comment on Edwards' TEER data and just how you're thinking about marketing that relative to your low-risk data as well. I have a follow-up.
Why don't you take that, Nina?
Yeah. Kristen, we just saw the data like all of you this morning. We're in the process of trying to absorb it. I think there are questions about thrombosis that I'll have to dig into that. Really, what we look at is our own data. 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 the hemodynamics. 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 Evolut technology out to eight and nine years.
I think overall, the TAVR continues to show strong data results, which is a positive. When physicians make device selections, these are the things they're going to have to weigh.
Okay. I know you were talking about your HALT data. Is there anything that would explain the higher rates of, I guess, HALTs in your SAVR group relative to what they had in their group? It looked like your rates in SAVR were particularly higher than what they were showing in their study.
Maybe Pieter, you can take that.
Yes, absolutely.
No, thanks. It's very difficult to compare one study to the other one. Because there are still differences in patient characteristics, because they're two different patient populations, although they're both called low risk, but there will always be differences. The other thing is that we have different definitions in valve thrombosis between the two studies. Evolut has a different definition for valve thrombosis compared to PARTNER. What you can do, you can compare SAVR versus TAVR in each study, but it's hard to compare one outcome from the Evolut trial to the outcome of the PARTNER study.
What we do see is that in our study, we have consistently lower thrombosis rates compared to the SAPIEN 3, while they, in the PARTNER 3 study, is the other way around.
Okay. You're saying you can compare within your study, but you can't compare across to other studies?
Across the studies. Exactly. We have lower rates compared to surgery. They have higher rates compared to surgery.
Kristen, that's because, as Pieter said, they're two different patient populations, and also two different definitions for what thrombosis is.
Okay. All right. Thanks very much.
Okay. Thanks, Kristen. Let's go next to the line of Matt Miksic. Matt?
Hi, can you hear me okay?
Yes.
Yep. Great. Thanks for letting us offer the questions, and hope everyone is safe and well. A couple of follow-ups, I guess, on some of the questions you've been getting on TAVR. One is for Professor Kappetein. The 60% bicuspid number that you offered around in the low-risk patients. If you could maybe provide some color on what percentage do you see in Sievers type 0? The most extreme, I guess, two 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 as a % of total that represents. I have one follow-up.
Yeah. In our study, 10% of the patients had Sievers class 0 and the rest had Sievers class 1. That's the breakdown compared to Sievers classification.
Okay. If you were to say X% of low-risk patients are in this Sievers class 0 group, what percent would that be, do you suppose?
The patient with Sievers class 0 might be a little bit higher in the, let's say, for the 60%, because they mostly have very heavily calcified valves. Of course, we left it to the discretion of the site whether the patient could be included in the study. What we do know from the screening data that also Jeff Popma presented in his presentation, there were some patients excluded because the valve was considered so heavily calcified that a TAVR would not be preferred. That's just a very small percentage of the total patient population.
Great. Maybe a follow-up for Mike and Nina just around, you mentioned the Micra 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 training or volumes in kind of the pacer segment in the U.S. at the moment?
Yeah, it's a good question. Obviously, we got approval for the product here in the United States, really the last week of the last quarter. In the following week, we were able to get the reimbursement aligned. We had pretty much a full quarter start with the launch. Frankly, it was going ahead of what we had expected in terms of 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. We're very encouraged by that launch.
As you point out, there are arguments for using it that are even more compelling now with coronavirus in that the complication rates associated with the pacer implants when you use a Micra versus a conventional dual chamber system are basically cut by 2/3, based on our clinical evidence that supported its approval. A hospital that's worried about using up ICU beds, that's a pretty compelling argument. 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.
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. 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, that it will point to why this technology should become much more widely used in patients with AV block.
Thanks so much, Mike.
Yeah. Thanks, Matt. Let's go next to the line of Josh Jennings. Josh?
Hi. Thanks, Ryan. I was hoping I'd just ask on renal denervation, just a $1 billion market opportunity globally. Can you help us think about U.S. versus outside the United States and the percentage of that TAM? Just remind us where your EU or international RDN business is. Are there any countries that have put reimbursement in place for renal denervation procedures?
Go ahead, Dave.
Sure. With regards to that billion-dollar market potential, we see this playing out similar to other new therapies and the way they grow, the way we have it modeled. By the time it's a billion-dollar market, sometime around that 2026 time period, assuming things go in the right way with regards to reimbursements and guidelines, et cetera, 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 ON-MED data. 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 denervation 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 ON-MED data. The trajectory increase will really increase more so from that ON-MED 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. I hope that helps.
That's great. Thanks. Just one follow-up on Low Risk Bicuspid data. Pieter, if you could just remind us, you mentioned that Edwards finished their enrollment in their registry, I think, in mid-year 2018. Can you remind us when Medtronic finished their Low Risk Bicuspid registry enrollment, when we could potentially see one-year data? Is one-year data essential for that precaution and the low-risk label for bicuspid patients essential to be removed? Thanks a lot.
Yeah, no, it's a great question. I think the one-year data is extremely important because what you would expect is that the complication would occur around the procedure. One of the procedures that physicians fear most is, for example, annular rupture. What we have shown is that in our data from the 150 patients, that was zero. 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. I think that's a major advantage of the self-expandable valve. We hope that, of course, that also we will see the adverse data.
That's the expectation that they may present at the TCT, but we're still wondering why it's so late, because we think it's an important patient population for low-risk patients. Therefore, that is, I think, very important. I think what we also want to do, we will follow the patients for 10 years. We also know what the impact is on valve durability. 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. We have shown now that that's very similar to trileaflets.
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?
Yeah. Hi, good morning. Can you hear me? Hello?
Yep. Can hear you.
Yes, we can hear you.
Okay. Sorry about that. It is my first time actually using this Webex thing. Just two questions on renal denervation. I will ask them together because they sort of go hand in hand. One of the things I noticed in the comments during the presentation 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. I am asking that question as it relates to, are you going to take a look at certain subsets of patients? I am curious what is informing the $1 billion market opportunity by fiscal 2026, because obviously there are tons of patients out there. What sort of patient is going into that $1 billion 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? That's all for me. Thanks.
Go ahead, Dave.
Sure. Maybe Dr. Mauri should respond to that first question.
Sure
subset where you might see a more significant response.
Yeah. Of course. I'll throw it back to you, Dave, for the second part of the question. For the first part, well, within the OFF-MED 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. 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 denervation that the higher the starting blood pressure, the more the magnitude of the response is. 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 will 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 OFF-MED study with the large population of self-referred 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.
Then, Danielle, to answer the second half of your question about how do we think about this billion-dollar 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 the patients who are good candidates. I'll just reiterate, I think where it starts is similar to what you saw with where we started with HTN-3, frankly, where physicians are going to be most likely to refer patients initially are the patients where 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. That also happens to be the smallest of the pools of patients. There's a lot of interest both by physicians and patients and payers in those higher-risk patients.
These are the patients that have lots of comorbidities. They're at 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. Finally, and this is a really important patient pool, is the non-adherent patient. Don't underestimate how important this is. Even patients who are younger, who are being newly prescribed medication, and they're facing a potential lifelong polypharmaceutical approach to managing their hypertension. What we're seeing in our trials, including in our OFF-MED trial, is the vast majority of the patients that we're getting is that type of patient who says, "I just don't want to do that," and so they're self-referring for this. Those are kind of the main patient groups that we're looking at.
How we get to that billion-dollar market is kind of a combination in the same way you guys model. You look at top-down in terms of what the penetration is for therapies. Particularly a therapy like this where the standard of care is actually pharmaceuticals instead of surgery. We can look at similar therapies and over time how quickly they penetrate, 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, Danielle. Let's go next to Chris Pasquale. Chris?
Thanks, Can you hear me?
Yes.
Okay. One for either Nina or Pieter and then one for Dave. Pieter, 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 SAVR in bicuspid patients. Given how important this patient subset is that something you guys plan to do? I'm wondering, given your comments about the potential superiority of Evolut, would you make it a three-arm study where you can actually have other commercially available TAVR arms there and try and show that difference?
Yeah, that's a good point, and there's a lot of discussion about whether a randomized study should take place. I think the major concern that a lot of people have is whether 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. There are a lot of patients that have comorbidities, so they're discussed with the heart team, and whether the patient is not better off with a transcatheter trial. It is a lot of discussion about that topic, and we know that the FDA wants to convene a meeting to discuss this. Actually, there was something planned with industry involvement as well as physicians and societies. Whether that will still take place due to the COVID-19, probably there'll be a virtual meeting to discuss this.
The major concern, as I just said, is the feasibility of the trial, whether you could enroll enough patients in timeframe. We have to wait and see what comes out of that meeting. What we have seen 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 bicuspid patients as with tri-leaflet patients.
That's helpful. Thanks. 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 and proving that point to payers? 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.
Yeah. 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 renal denervation. Is that?
Yes.
Is that what you're asking? Yeah. I think Dr. Mauri 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 studied disease, and just blood pressure as a surrogate for hard endpoints is one of the best established surrogates. 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.
Yeah, 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 endpoints. For renal denervation, you have the added impact of the known adverse effects of non-adherence to medications and the effect that has on cost. I think those are the lines of evidence to support that coverage.
Laura, you may want to comment, the data that Dave showed on the two millimeter of mercury decrease leading to a 10% reduction mortality or stroke mortality and 7% reduction in ischemic heart disease mortality. These are huge meta-analyses done over very large patient sets. There seems to be a view of that being indisputable that linkage is there.
Yeah, that's right. There's so many randomized trials comparing antihypertensives agents, there's just a strong body of evidence for the link between blood pressure as an endpoint and clinical endpoints, and 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. On RDN and specifically, just given that enrollment is paused, what are you guys doing to ensure that things still able to track down follow-up patients in this interim period? 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, you could comment on that.
Sure. Yes. FDA and other regulators have been very active at providing guidance. 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, et cetera. They have indicated that they will have more flexibility in terms of using remote methods for follow-up. Their goal really is for us to preserve the integrity of the trials while also making it feasible to preserve the safety of patients who are enrolled in studies. 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. 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. Thank you for your continued support and interest in Medtronic, and please, everyone, stay safe out there. Thanks, everyone.