Medtronic plc (MDT) Earnings Call Transcript & Summary

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, and 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 by 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 2, 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?

As 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 datasets specific to our renal denervation and our TAVR businesses. But 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. But most of the presentation and the Q&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, that -- Nina, the TAVR presentation will focus on 2 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. And Professor Pieter Kappetein, who is the Vice President of -- and Chief Medical Officer for our Structural Heart Group, will join on those data presentations. And then finally, we'll open it up to a panel Q&A. And in that session, I've asked Dr. Laura Mauri, who is the Medtronic's VP of Clinical Research and Data Analytics, to join us as she is intimately familiar with all of the datasets that are going to be -- and 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-19 impact. As you know, as Ryan said, we are still 2/3 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 in 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 impact 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'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. 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 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 the 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 LINQ as well as our AF ablation procedures to be more in the 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 to want to increase their on-hand level of supplies. So those are things that actually are showing acceleration versus what we've 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're 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-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. 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 Evolut PRO+ family and the low-risk and now bicuspid data being made available on the DCB side or AV access product entry. And this quarter, we have now launched the micro AV transcatheter pacing system. In addition, our next generation of ICDs, the Cobalt and Crome families, have now been launched into Europe and will be launched into the United States during the first quarter. And we would also expect during the first half of next year to see important new products such as the DiamondTemp RF ablation system and REVEAL LINQ 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 have -- carry a lot of interest: the RDN 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. 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 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. And then we also presented extended data from the WRAP-IT study risk stratification for TYRX as well as a 3-year confirmatory data on the sustainability of the benefit that TYRX brings in infection reduction. And of course, if there are questions about it, we can also talk about how micro AV 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 Moeller, and we will begin with the RDN 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 of 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 ON MED trial enrollment is currently paused in most centers due to COVID-19. The SPYRAL HTN-OFF MED pivotal trial proved that RDN works in the absence of medication at 3 months. So the primary end point tells us that RDN 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 with a baseline of 151 for 24-hour blood pressure and 163 office blood pressure. The renal denervation arms 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 OFF MED 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 1 million people, we learned that even a 2-millimeter drop in office systolic 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 2 reasons: First is the duration of follow-up. In every RDN 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 blood pressure went above 180 office, they were excluded from the results and were considered escapes. There were, not surprisingly, significantly more escapes in the sham arm, which can cause an understatement of the difference between the 2 arms in the trial. Now 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/blue lines are at 3 months. What this shows is that renal denervation is always on. And this is significant because patients are at greatest risk for cardiovascular event in the 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 RDN. Now 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. 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, RDN 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 supports the durability 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 1/3 of adults and is the single-largest contributor to death. Now I think it's really important to highlight the magnitude of the nonadherence problem. Half of the patients are not 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, 2/3 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. Now let me just first say that we will be pursuing broad labeling upon initial approval of RDN. 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 meds. And it will expand to the exponentially larger pool of patients on fewer meds. And then 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 150. And to give you an idea of the dollars that this represents, a 1% penetration of the middle bucket would represent about a $1 billion market. So we've gained an understanding of the patient segment 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. 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 a 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 ON MED data, and enrollment in that study is currently paused due to COVID-19. Now pre-COVID-19, we were on track to complete enrollment in the ON MED 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 On MED 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. It could be a $1 billion market by 2026. Similar to other therapies, we think the U.S. will be almost half of that. Getting to a $1 billion 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. So 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're 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 logus 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 stated before, we believe the size of the TAVR market is about $5 billion. That's consistent with what we've been talking about, growing in the mid-teens. Also, as we stated before, with the NCD expansion, we believe we'll see about 800 accounts in the U.S. doing TAVR procedures. And then, 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 bicuspid valve, which makes this first to be presented in published data sets so incredibly important for patients. So 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, patient prosthesis mismatch, the ability to treat bicuspid valves and valve durability become 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 valves for patients. You'll see, as Professor Kappetein walks through the data sets, that we've continued to show benefits in mortality and stroke, PVL and the continued trend downward in pacemaker rates. I'm going to come back to that a little bit later. And so that's really why we're so excited to present these 2 data sets, both of which show excellent outcomes for Evolut in low-risk patients. So Pieter, let me turn it 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 the bicuspid anatomy is actually the most common congenital malformation, a heart malformation. And it results in that more than 60% of patients who are at low risk and who have an aortic stenosis have a bicuspid valve. Bicuspid valve is a specific type of valve in a heart disease because it's more complex, the anatomy is more complex, which increases the risk for annular rupture or paravalvular leakage for pacemaker implantation and for stroke. Bicuspid patients were actually excluded from low-risk trials, and they're 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% was over the size of 34 millimeters. And of course, these -- the results of these studies will be submitted to the FDA for a revised TAVR 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 aortic valve replacement by being the first 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 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. And we have seen that actually pacemaker rates continued to decline in real-world TVTR data at 12.8%. So encouraging is also that the MIDAS and cross-overlap techniques have demonstrated that low single-digit pacemaker rates are consistently achievable with Evolut. Now 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 2 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 shows 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 base in this page with SAPIEN 3. So excellent results here for both bicuspid and tri-leaflet patients. But important just to note that actually, there's 0 moderate or severe paravalvular 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 first and only company to present a low-risk bicuspid data. As far as we know, PARTNER 3 has also a bicuspid substudy 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. 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 Evolut platform in patient with bicuspid anatomy. So now I will transition to the leaflet thrombosis, thickening and immobility study. The leaf -- the LTI substudy and the PARTNER 3 CT substudy 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 were in the Portico valve. A leaflet thrombosis includes the presence of a hypoattenuated leaflet thickening, abbreviated as HALT, and reduced leaflet motion abbreviated as RLM. The aim of this substudy 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. 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 leaflet thrombosis, we know that increased gradients are tied to structural valve deterioration. And previous literature, including the PARTNER 3 CT substudy, showed the increase of gradients for patients with HALTs and/or restricted leaflet motion. The extent of the hemodynamic impairment in the presence of significant HALT or RLM may differ between supra-annular valves and intra-annular 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 leaflet motion was similar between surgery and Evolut. However, transcatheter aortic valves have significantly less HALT of more than 75% at 1 year. Important, of course, is now to look at the consequence -- the clinical consequences. And actually, there was no change on the hemodynamic performance with the extent of HALT. As you see, the yellow bars are the patients with a TAVR. And Evolut TAVR gradients remained 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 core lab 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 SAPIEN 3 gradients are impacted by a HALT of more 50% with higher gradients. Now if we look at Evolut, the LTI structure of valve deterioration, Evolut shows less RLM of more than 50% and consistent low single-digit gradient, while the peers at SAPIEN 3 grades are impacted when they have an RLM of more than 50%. And actually, that means even the criteria for structural valve dysfunction, which means that those valves have gradients of more than 20 millimeters of mercury. And here, I conclude the presentation of the data, and I hand back to Nina Goodheart.

Thanks, Pieter. So Pieter is the [ next ] person, thanks so much. So 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. 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 Pieter showed, excellent procedural success outcomes in mortality, stoke and PVL, and we continue to see a downward trend in pacemaker rate. 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 optimized 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 Evolut for all patients, but especially for low-risk patients. So while I'll end with a quick look at our TAVR pipeline, we've recently launched the Evolut PRO system with its lower profile and has 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 positioning, accuracy and visualization of our system, and we also continue to innovate as we focus on lifetime 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 for Q&A.

Yes. Great. Thanks, Nina. We will now open the event to questions from the sell-side analysts. And 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, and that will let us know that you've got a question. And then we'll call on you by name and unmute your line. [Operator Instructions] 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, I will 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. I assume you can hear me, Ryan. I have a couple of questions here. I'll just 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 RDN 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 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 RDN effect may actually have been understated a little bit given this confidence of safety escape. We'd just like to hear a little bit more detail on that from you guys.

Thanks, Bob. Why don't I just turn that over to Dave Moeller?

Sure. Can you hear me?

Yes.

Yes.

Great. So with regards to the first question in terms of timing of completion of enrollment of the ON MED trial and filing, the plan was -- so if we -- keep in mind that the ON MED trial has a different end point than the OFF MED trial. It's a 6-month end point. 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 end point, 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-19?" But that should give you a good -- a 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 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. Yes, great question. So what -- with the way the trial was designed, there was a mechanism for patients who have 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 medications. And what happened is that they were unable to complete the trial end point, 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-treated patients. And so that biases the results to be more in favor of the sham arm that 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 what -- 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 time lines. So for Micra AV, 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 when we generate the ON MED data sets, but it is encouraging that we have a very good collaborative relationship with the FDA on this particular technology.

Thanks, Bob. Let's go to the line of David Lewis.

Can you hear me okay?

Yes, we can.

Great. David, just 2 questions for you. But firstly, 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- 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? And 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 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. 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 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. And so what we've seen in every trial and including ON MED is that, that magnitude of effect continues to progress beyond that 3-month period. And in fact, what we see beyond that in our Global SYMPLICITY Registry, which is a less rigorous, that it goes beyond that 6-month period as well. I'm not sure if that covers both your questions.

No, 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 Cat III reimbursement for denervation? And do you think that level of reimbursement is going to be significant enough for near-term adoption?

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?

Sure. So the Category III, so 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, so we're going to be working both angles at once. 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 I code. And that just means that 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?

Ryan, can you hear me okay?

I can.

Great. 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 ON MED data?

No. I think we're going to need the ON MED 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 can 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, Larry. I think as Mike Coyle talked about in the last earnings call, it became very clear to us that we were underpenetrating 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. We're -- 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-19, 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-19, we'll continue to see that.

And 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 longevity for a supra-annular design, which is obviously something that we're going to be pushing aggressively into our accounts.

That's exactly right, Mike. Thanks.

And 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. 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-19 in low risk?

Why don't you take that, Nina?

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 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 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 the FDA to get the labeling restrictions lifted.

Great. And 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 $1 billion in sales. So 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?

Why don't you take that, Dave?

Yes, 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. 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 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 United States, but we will do what we can, and we'll be prepared, and we're learning, through our now getting to be a very extensive experience in enrolling clinical trials, how to develop that market, particularly in the 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, Robbie. Let's go next to the line of Vijay Kumar. Vijay?

Two for me. One on the RDN data, the 2 you guys presented. Appreciate the color on the market opportunity sizing. The 2026 $1 billion time line, I'm assuming that contemplates the delay in filing here. And we've heard some rumblings around procedure claims 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.

Go ahead, Dave.

Thank you for that question. So let's talk about the $1 billion market. We're talking about a matter of -- hopefully, a matter of months, a few -- very few months, hopefully, in delay, which results to this -- as a result of the COVID-19. So hopefully, that doesn't necessarily change dramatically the timing of when it can become a $1 billion market. But obviously, it's a month-per-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 denervation 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 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. And so that's why we've kicked off -- well, of course, now it's delayed with COVID-19 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. 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 as we consider technologies.

That's helpful. And Mike, one quick follow-up for you. I think -- I appreciate 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?

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 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. But I can tell you, we're looking very carefully at China and in 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?

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 I have a follow-up.

Why don't you take that, Nina?

Yes. Kristen, 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 that we'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 Evolut technology out to 8 and 9 years. And so 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. And then I know you were talking about your HALT data. Is there anything that would explain your -- the higher rates of, I guess, HALTs in your SAVR group relative to what they had in their group? Because 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. Thanks. So it's very difficult to compare one set to the other ones. 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 valve thrombosis between the 2 studies. Evolut has a different definition for valve 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 Evolut trial to the outcome of the PARTNER study. But what we do see is that in our study, we have consistently lower thrombosis rate compared to the Symp arm, while they -- in the PARTNER study, it's the other way around.

Okay. So what you're saying is you can compare within your study, but you can't compare across to other studies?

Across the studies, exactly. So we have lower rates compared to surgery. They have higher rates compared to surgery. That's...

And Kristen, that's because there's, as Pieter said, 2 different patient populations and also 2 different definitions for what thrombosis is.

Thanks, Kristen. Let's go next to the line of Matt Miksic. Matt?

Can you hear me okay?

Yes.

Great. So 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's sort of being offered around into low-risk patients, you could maybe provide some color on how many -- what percentage do you see in Sievers Type 0 or the most the 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 as a percentage of total that represents? And I have one follow-up.

Yes. So in our study, 10% of the patients had Sievers class 0 and the rest had Sievers class 1. So that's the breakdown compared to Sievers classification.

Okay. And so -- and that -- and if you were to say x percent of low-risk patients have -- are in the Sievers class 0 group, what percent would that be, do you suppose?

So the patient with Sievers class 0 might be a little bit higher in the -- let's say, from the 60% because they mostly have very heavily calcified valves. And of course, we left 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 Popma presented in his presentation, there were some patients excluded because the valve was considered so heavily calcified that TAVR would not be 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 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 any -- and 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 approval for the product here in the United States really the last week of the last quarter. And then in the following week, we're able to get the 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 in that the complication rates associated with the pacer implants when you use the Micra versus a conventional dual-chamber system are basically cut by 2/3 based on our clinical evidence that supported its approval. And so 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, that it will point to why this technology should become much more widely used in patients with AV block.

Yes, thanks, Matt. Let's go next to the line of Josh Jennings. Josh?

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? And just remind us where your -- you or international RDN businesses, are there any countries that have put a reimbursement in place for renal denervation procedures?

Go ahead, Dave.

Sure, sure. So with regards to that $1 billion 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 a $1 billion 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. 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 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. And so it is going to -- the trajectory increase will really increase more so from that on the data. And 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 at your TAVR/TAVI. Can you just remind us -- you mentioned that Edwards finished their enrollment in their registry, I think, in midyear 2018. Can you remind us on 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 and the low-risk label for bicuspid patients essential to be removed?

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 patients, 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-expandable valve. And so we hope that -- of course, that also that we will see the Edwards data. There has been some speculation that they may present it at 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, that is, I think, very important. So I think the -- 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 patients with bicuspid valves. And then we have shown now that that's very similar to tri-leaflets.

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. Can you -- hello?

Yes, we can hear you.

Yes, we can hear you.

Okay. Sorry about that. It's my first time actually using this WebEx thing. So just 2 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 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. 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 billion market opportunity by fiscal 2026? Because obviously, there's tons of patients out there. So 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? And that's all for me.

Go ahead, Dave.

Sure. Maybe we should -- maybe Dr. Mauri should respond to that first question about the subset where you might see a more significant response.

Sure. Yes, of course. And then I'll throw it back to you, Dave, for the second part of the question. But for this 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 the group. But we don't really see any particular pattern of one group that benefits over another. That being said, what we know from the large bodies of evidence for renal denervation is that the higher the starting blood pressure, the more the magnitude of response is. And so that fits, I think, with what many physicians will initially feel most comfortable with, meaning that patients who have more pronounced hypertension will be the types 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 was the large population of self-preferred patients, which is not 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 billion market potential by 2026 or around that time frame. 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 HTN-3, frankly, where physicians are going to be most likely to refer patients initially are the patients where they are 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 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. 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 prescribed medication and they're facing a potential of a lifelong poly-pharmaceutical approach to managing their hypertension. And what we're seeing in our trials, including in our OFF MED trial, is 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 the -- those are kind of the main patient groups that we're looking at. And how we get to that $1 billion 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 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.

Thanks, Danielle. Let's go next now to Chris Pasquale. Chris?

Can you guys hear me?

Yes.

Okay. One for Pieter and Nina or Pieter and then -- and one for David. 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, is that something you guys plan to do? And I'm wondering, given your comments about the potential superiority of Evolut, 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 be take place. But 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. Then there are a lot of patients that have comorbidity, so they're discussing the heart team and whether the patient should -- is not better off with a transcatheter heart valve. So it is a lot of discussion 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 tied with physicians and societies. But whether that will still take place due to the COVID-19, there probably will 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 a certain time frame. 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 are pretty confident that this data set is so good that our bicuspid valve will perform as good as in bicuspid patient as with tri-leaflet patients.

That's helpful. And then, David, just following up on the magnitude of 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? And do you have any plans to try and show that in a subsequent study? Because 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 end point trial to convince either referrers or payers of the efficacy of renal denervation? Is that...

Yes.

Essentially what you're asking? Yes. I think -- and 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 end points is one of the best-established surrogates. 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 end point. And then for renal denervation, you have the added impact of the known adverse effects, that is non-adherence to medications and the effect that has on cost. So I think those are the lines of evidence to support that coverage.

And Laura, you may want to comment the data that Dave showed on the 2-millimeter mercury decrease leading to the 10% reduction in mortality -- reduction in stroke mortality and 7% reduction in the ischemic heart disease mortality. These are huge meta-analyses done over very large patient tests, and there seems to be a view of that being indefutable. That linkage is there.

Yes, that's right. I mean there -- 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 end point and clinical end points and that continuous -- the continuous nature of that effect, meaning that there's a greater response to reducing stroke and cardiovascular mortality.

Okay, thanks, Chris. We'll take one more question. Let's go to Kaila Krum. Kaila?

I'll just stick to one given the time. So on RDN and specifically ON MED, just given that enrollment is paused, what are you guys doing to ensure that they will still be able to 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.

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, et cetera. 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 trial while also making it feasible to preserve safety of patients who are enrolled in studies. And so we will work -- we'll be working closely, and we have been working closely with the sites to do whatever we can within that framework.

Thanks, Kaila. So I think we will stop there. We will 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.