Good afternoon, everyone. Thank you very much for joining Boston Scientific for this update on our rhythm management portfolio from the Heart Rhythm Society meeting here in Boston, Massachusetts. Thanks very much everyone joining us here in the room, as well as on the webcast. My name is Susie Lisa, and I lead our investor relations effort. Very pleased to have joined with us this morning, Joe Fitzgerald, who runs our rhythm and neuro business. We're focusing on rhythm management here today, as well as Ken Stein, who is our Chief Medical Officer for rhythm and neuro, as well as the Global Health Policy. Then Mark Bickel is our Vice President and Global Controller for the rhythm and neuro segment. We'll get right into it.
The usual risk statements and forward Excuse me, safe harbors and risk statements apply. We'll spend some time giving an overview of the portfolio, then leave a lot of time for your questions. Joe?
Perfect. Joe Fitzgerald, President of the Rhythm Management Neuro Segments. We've shown you this slide before. The reason we're proud of this slide is over the past six or seven years, we think we've built a highly innovative, disruptive and competitive portfolio stemming from our early roots in just a basic EP company and a CRM company, now to include things like left atrial appendage closure, complex mapping and navigation, a global leadership in the leadless or modular segment with S-ICD and a lot of exciting stuff. We're going to spend some time on this today in our diagnostics and monitoring. We're going to specifically focus on our LUX-Dx implantable cardiac monitor.
As Ken always reminds me, we also have a rich history of supporting these innovative technologies that we bring to market, with sort of best-in-class clinical evidence to support that. Ken will highlight that throughout our presentation. Very similar to what I showed you at our annual stay in New York back in 2017, we have four key objectives specific to our rhythm management position. What you heard Mike say on the Q1 call is through our transvenous offense, through our S-ICD offense, we have clearly reestablished Boston Scientific as the number 2 high voltage player around the globe. That is a significant move that has been orchestrated over literally the last six and a half years. Our main objective is to expand that CRM leadership position that we're back into now. Secondly, we've been on quite a journey in our electrophysiology business.
In product segments, we went from basically just an ablation and diagnostic catheter business, now to a full portfolio of mapping, navigation, a full suite of navigable catheters, and we're scaling that business, and we're pretty proud of our success there, and we have a lot in the portfolio, and we'll talk about that on several slides. There are new segments. The one that we will talk about, we'll focus on today, two new segments. Our entry next year into both the diagnostic, implantable cardiac monitoring segment and where we're going into the world of leadless pacers and modular therapies in CRM. I've invited Mark, who's really been the key architect of our profitability journey since 2012.
I brought him on board today, and I think he'll give us some good insight and show you our confidence in hitting that about 400 basis points of improvement from today through 2020 across the rhythm management segments. You've seen this slide before, slide five. The items highlighted in blue. We obviously don't have the time to go through everything, we're going to focus and try to give you some inspection on the key items here across our core CRM portfolio, our diagnostics and our EPs, and the things noted in blue are things we're going to highlight today. Still a lot to go through, so I'm going to quickly jump ahead. As you saw in our Q1 results, globally, we grew our high voltage business in the double digits.
The bottom line answer to that is the global launch of our Resonate family of high voltage devices. They of course, as I've talked about numerous times, include our EnduraLife battery technology, which has proven to be the world's longest-lasting high voltage batteries. We are now into things in our smart CRT segment, things like multi-site pacing, new trials and studies on smart delay. Ken will go through some of that. We have checked the box on 1.5 Tesla MRI labeling virtually all around the globe, and we're very close to checking the box on 3T labeling on MRI. Obviously, the thing that we think is the absolute most differentiated algorithm that we brought forward on Resonate is our HeartLogic suite of physiological sensors to predict impending exacerbation or hospitalization of heart failure patients, driving real differentiation across our high voltage portfolio.
I will remind everybody that this family essentially got approved at the end of September, and we have been consistently ramping sort of the offense with the Resonate family all around the globe. With that, Ken, I want you to talk just for a moment at the appropriate level, what is HeartLogic? Why is it important? Why did we get the only FDA approval for a predictive heart failure alert? What are we building on the clinical evidence around it in the years to come?
Sure. I think it's important to say about HeartLogic that it's multiply unique. The first thing that is unique about it is it's the only diagnostic algorithm for heart failure and proven to predict impending heart failure decompensations with a sensitivity of 70%. Those three quarters of these events can be predicted, and are predicted with a median alert time of over a month, 34 days. Physicians clearly have the time to intervene if what's going wrong is reversible. As we've seen it roll out both commercially and in clinical trials, I'll get to the trials in a second, we see many episodes where it's actually really simple changes that need to be made for a patient that can get them back out of the alert status. It's also unique in a second important respect.
It is the only FDA-approved alert as a diagnostic implantable for heart failure. That's really important when we think of the impact that it has on workflow for busy clinicians. I mean, it really changes the paradigm. Instead of just every day or every week having to log on to a web server and go through a whole list of patients, really what clinicians can do at this point is, and they'd hit me for using the word, but they can ignore it until and when an alert gets transmitted to them. The alert frequency with this is low enough that we actually see an opportunity here for physicians to decrease workload while getting this benefit for patients. We are, as Joe said, testing this in a series of clinical trials. There is a randomized clinical trial, MANAGE-HF. That's a two-phase trial.
It's in its first non-randomized phase right now, that is a trial designed to quantify the benefit in terms of mortality and heart failure hospitalizations for clinics who use HeartLogic versus those who don't. That's being supplemented by a very large real-world registry that's called PREEMPT-HF, enable us to see how well those benefits translate outside of the randomized trial setting into more of a real-world setting. Finally, with commercialization, beyond clinical trial work, we're also engaging a series of economic value pilots with various healthcare systems, both in the U.S. and abroad.
Mark was one of the key architects of our risk share program. Mark, do you want to make a couple comments on laying out with that?
As part of the commercialization of the Resonate family in the U.S., we have offered a broad-based risk share on the Resonate platform for eligible customers. It really stands behind if a patient has a decompensating heart failure event that is not detected by the HeartLogic algorithms , we pay for performance. I think we have seen a ton of physician excitement in the U.S. market at this point with this algorithm.
That kind of wraps up the core CRM portfolio, kind of explains how and why we grew double digits in Q1. We are very excited on the Resonate family. I will switch now to the S-ICD. As we said on the Q1 call, we are nearly 6 years into the global launch of this technology, and we are really proud that we still have double-digit growth in the S-ICD product category. Why is that occurring? Number one, it is the clinical benefits, and Ken is going to talk to some of the clinical outcomes and late breakers that we have had. We have also, as you know, a couple of years ago, delivered EMBLEM MRI for MRI compatibility. We have recently implemented an automatic screening tool, RF programmer. We have a new electrode insertion that facilitates the preferred two-incision technique on there.
We also introduced the SMART Pass algorithm, which again helps us to bring inappropriate shock rates down to or below what has historically been seen in transvenous systems. A lot of momentum. Ken will talk on the next slide about what we have seen on the guidelines and on the payer side. A lot happening in the core S-ICD, both the implant, the algorithm performance of SMART Pass and on the procedural enhancement techniques driving that 10% growth. We would now switch to a modular CRM approach. We have talked to you about that before. What does modular mean? Modular means incrementally adding to a defibrillator as the patient develops the need for bradycardia pacing and/or ATP.
The value proposition to clinicians is you have an indicated patient for an ICD who, as you have seen in our UNTOUCHED registry, we think very few of them over the course of their tenure with their S-ICD will develop a pacing indication. We are willing to test that hypothesis by saying we will make available our leadless cardiac pacemaker, called EMPOWER. That will be entered into two studies in 2019. One will be your standard single-chamber VVIR pacemaker, very similar to what Micra lead in the U.S. Then we will run a study where we incrementally add the EMPOWER pacing system to the S-ICD system to provide ATP burst pacing. That is in a kind of a master slave arrangement, but both of those, the product will finish development at the end of this year and will go into clinical trials in 2019.
Ken, do you want to make some other late breaker or two here? Do you want to give the overall clinical program?
I'd like to speak to some of these trials that are here as I can also speak, we have a late breaker that's going to be presented later on today. The results are embargoed, and I can't even hint to you what it's going to show. It does look at the effect of the SMART Pass algorithm with the S-ICD and provides very good quantification of just how effective that is in reducing inappropriate shocks. We're actually very pleased to be able to present those data. Joe mentioned UNTOUCHED, to just get yourself today on some of the other trials. That is our primary prevention registry. Again, won't have results on that until 2020. Likewise, I think everyone here is aware we've spoken about a randomized head-to-head S-ICD versus transvenous trial, PRAETORIAN. That is done with enrollment.
Again, we're expecting to see the outcome results on that in 2020. I think for the first time here, we can talk to you about the next PRAETORIAN trial, which is a trial called PRAETORIAN-DFT, which is a randomized trial looking at whether we can avoid the need for defibrillation testing in patients who are undergoing de novo S-ICD implants. I can tell you that we did have our first patients enrolled in that trial earlier this month. Joe mentioned to the timelines for the EMPOWER and MODULAR trials. I could go on with this, Joe. One of the things that maybe we haven't done a sufficient job of highlighting with you all yet, has been the recent update to the ICD guidelines.
The latest iteration of 2017 guidelines, for the first time, formally represented the S-ICD, including as a class 1 indication for patients with limited vascular access, et cetera, sort of the need-to-use population. Did include it as a 2A recommendation for that broad middle ground of patients who are getting predominantly primary prevention ICDs, but who don't have an established need for pacing or for CRT. That's been very impactful. One of the impacts that it had is it helped our health economics market access team through a lot of effort to get broadened coverage of the device from private payers. We've always had broad coverage from Medicare under the NCD. At this point, all major U.S. private payers offer some degree of positive coverage of the S-ICD. It does cover basically 92% of commercial covered lives.
What we can tell you today is that both Cigna and United recently updated their policies to broaden them and to be consistent with our labeling and with the guidelines which broaden coverage for 41 million lives in the U.S.
Okay. We're going to talk about next, we're going to move from transvenous CRM and modular CRM with our S-ICD. I'll give a couple of comments about our LUX-Dx insertable cardiac monitor. We intend to complete development, verification, validation, et cetera, later in 2018. We're looking at a market launch in both Europe and the United States in 2019. Couple of things about the system. We think it is going to be a highly competitive form factor, use factor, and implant technique. We have great visibility to see two of our competitors with similar devices in that sub 2cc range to be able to state that. I would also point out that we feel really good. Some of this is tied to the atrial diagnostics that we enjoy with the S-ICD.
Our algorithm performance to detect atrial arrhythmias, pause, bradycardia, tachycardia, we're really confident they're top-notch, and we're going to have a high-performing suite of detection algorithms to do that. We will also offer a mobile solution, either via a dedicated phone or a patient's smartphone, to enable easy transmission to the cloud for monitoring of their patients. Obviously, this is highly synergistic with our core CRM sales forces around the globe and other call points within the broader cardiology community. Again, work on this gets done later this year. We will submit to the two, both CE mark and FDA, we will be launching in 2019. Ken, anything I forgot about that?
No, I think you got that all right, Joe.
Okay. Thank you. Okay, let's switch to WATCHMAN. Ken and I will share this. Our latest count is we are greater than 50,000 implants worldwide. China is already poised to become our number two global market behind the U.S. In Japan, we finished a clinical study. Ken may want to comment on that. We finished enrollment in the Japan study, and we're targeting a 2019 launch in a very key market. We regularly update you. This says at the end of 2018, we think there'll be 500 of the largest cardiovascular centers in the U.S.
As you've seen in many of the publications dating all the way back to TCT a year ago, one of the things we're most proud of is that the safety profile in our gradual launch at minimum matches what we showed in PREVAIL and CAP, and actually trends favorable to that acute complication rate that we saw in those pre-market studies. Ken, you want to comment on FLX and NESTED registry?
Let me do that. We presented the first results of our FDA-mandated post-approval study, NESTED, at ACC earlier this year. There's acute implant data in 1,000 patients, and again, this is a comprehensive registry. Under the CMS NCD, every patient gets entered into it. We were really pleased at this point from a 1.5% major adverse event rate at implant. Again, I'd rather it be zero than 1.5, but 1.5 is actually lower than it was in our clinical trials, and it is far lower than any other procedure that we know of that's performed in the left atrium. I think it's just been a testament to the way we rolled this therapy out, and to the diligence in training and the diligence of implanters. I think that's played a big role in the overall success of WATCHMAN.
Really exciting news to share with you. We've talked to you previously about the next generation WATCHMAN device. That's the WATCHMAN FLX. It's different from the previous device in that it's got a closed distal end, in that it's got more struts, so it's more conformable to the ostium of the left atrial appendage. Also, it is shallower and comes in a wider range of sizes, so it can be used for a wider range of appendage geometries. Can inform everyone today, that we have had our first implants in our U.S. IDE trial, which is called PINNACLE FLX, and we had three enrollments that went in on this Monday. All three were quite successful, so we're pleased with that.
I do want to correct one misstatement that was made at our last earnings call, which is that the FLX trial is a U.S. trial, and we are not enrolling patients in the FLX IDE in Europe. I think, just want to make mention of a late-breaking trial that was presented today on device-associated thrombus with WATCHMAN. Really was important data to get out there. First off, it confirmed the rates of device-associated thrombus that we've previously published in the range of 3%-4%. It's clear that those patients who have thrombus do have worse outcomes than those who don't. That's not particularly surprising. I think for us, the real importance of this data is it highlights the need for careful patient selection, highlights the need for follow-up and medication and prescription as per our labeling.
What's reassuring for us is, first off, the vast majority of those cases were able to be managed medically without any adverse event. In fact, when you look given the relative infrequency of device-associated thrombus and then the relative infrequency of stroke in those patients, actually strokes due to device-associated thrombus were very rare in our clinical trials, and that overall, the outcomes with the device are still clearly comparable to outcomes with warfarin and far better than the outcomes for patients who aren't taking anything to protect them. In fact, I actually thought the more important presentation at that late breaker was one that came a little earlier, which was a really large real-world evidence look just at usage of warfarin and NOACs that really highlights the issue of non-adherence to those medications and shows, unsurprisingly, if you don't take a pill, it's not effective.
To us, really highlights the important role of WATCHMAN in high-risk patients who have a reason to seek an alternative to anticoagulation.
I think qualitatively, too, the role of the electrophysiologist, which is our core customer in Rhythm Management and sort of the progression of the penetration and the therapy awareness and the education of the referring cardiology community is super important. I don't know if any of you were at the Tuesday stroke LAAC meeting, but I think that is one of my most favorite meetings of the year, run by Vivek Reddy, covering a whole range of topics pertinent to the LAAC space. That was great to see as well. Switching gears now from WATCHMAN to our electrophysiology portfolio. Business line, we are highlighting a couple of things. We've been on a journey starting in very late 2014, where we are essentially launching a novel disruptive mapping and navigation technology. That began with just the hardware and software in what we call Gen 1 RHYTHMIA.
Today, we sit globally, largely with approval for HDx in all major markets, several major markets. We have converted most of our ablation catheters to be compatible on the magnetic navigation platform. We've just got approval in the U.S., and we just launched last week for our last product in that sort of portfolio. We have, whether you look at large tip, small tip, open irrigated catheters with MiFi electrodes, we now have the full suite of our ablation catheters. This is really important because magnetic navigation is clearly the preferred localization and navigation technique around the globe for complex arrhythmias. Today, we sit here with a fairly robust lot of work done by our R&D teams with HDx approved, with all of our ablation catheters, our historical legacy ablation catheters approved.
We're going to talk about some of the other things that we're going to launch, I'll do that on the next slide in 2018 and 2019. We're also going to highlight our acquisition of Apama, a single-shot RF balloon, and the Securus novel esophageal temperature monitoring system that we just announced, I believe, in April. Okay. Let's look at our 2018 portfolio. I already talked about the NAV-enabled. That's virtually our full portfolio, covers 99% of the type of catheters and ablations that we would do. I have to differentiate where we're on market and where we are approved. The next thing that comes is what we refer to as our DIRECTSENSE technology.
This is our 2.0 Vidria software, that is actually already approved. We've been in a limited market release in Europe for the past six months. We will go to full market release with 2.0 DIRECTSENSE technology, which we think is super novel. It is tied and paired with both our HDx hardware, 2.0 software, and our latest generation catheter, which is the INTELLANAV. It means it's got a NAV sensor in it. It's an open, irrigated catheter, and it has these, I don't know if you can see it on this slide, but We're the only company in the world, but tiny mini electrodes. That enables us to do things that I don't believe any other company has demonstrated or disclosed yet in this area of impedance modeling at the catheter tip interface.
That is full launch in EU this month. We're still pending FDA clearance on that technology. We expect it sometime in calendar year 2018. The third column is what we refer to internally as 3.0 software, it's Lumipoint. I don't think we have any electrophysiologists in the room. You're a retired electrophysiologist, Dr. Stein. That still counts. We are super excited about this. This takes these unbelievable high-density, high-quality maps where we say we have a 99-plus% accuracy in accepting and rejecting these massive high-density maps. Think of this as a suite of software algorithms to rapidly sort of figure out what do those maps tell you. Whether it be people who want to look at complex, fractionated split potentials, no one has ever done this in mapping and navigation. 3.0 software, it's done.
I'm not going to try to talk to you about regulatory approvals because software does and does not sometimes need to have regulatory approval. Our expectation is this will launch by end of year in both the U.S. and in Europe. Again, think of that as our third-generation Vidria mapping software. We're going to go through each of these. Ken, do you want to cover this and talk about sort of our 2019 and beyond EP technologies?
Absolutely. First is where we continue to iterate just in terms of traditional single point RF catheters. Joe mentioned to you DIRECTSENSE, which is going to be embodied in the NAV MiFi OI catheter . Next after that is to have our own proprietary force-sensing catheter. Again, we recognize the adoption of force in the marketplace for those folks who are still using point RF catheters, and expecting CE mark on that back half of 2019. Going beyond point RF to "single shot," we are really excited about the possibilities of the Apama RF balloon catheter. It is again multiply differentiated from any other product that's been out there. It's an RF balloon.
It has two sets of electrodes, one around the equator that can be used to ablate, but also a set of electrodes on the distal surface, which gives a lot of flexibility for the lesion pattern which you want to put in, depending on how the balloon is oriented relative to the vein. The really cool thing about it is you know how the balloon is oriented relative to the vein because it does have four integrated LED cameras. You get full endoscopic visualization of the pulmonary vein ostium before, while, and after you ablate. What we're seeing already in our first human use trials, the AF-FICIENT I trial that's been conducted in Europe and in New Zealand, has been wonderful. Huge success with this, but also blazingly quick procedure times because of just being able to see things lets you see things.
We'll show you a video of that on one of the next slides. We got it better.
Last is the Securus, which again, we mentioned as a novel technology for monitoring temperature in the esophagus. The big fear with almost every energy technology that's used to ablate within the left atrium is the fear of esophageal damage. People conventionally use thermistor probes for monitoring temperature in the esophagus. Those probes are not designed for that use. They're designed to measure core body temperature, and they're really poorly reactive. What most EPs do is use a temperature cutoff of 39 degrees to say above that, it gets dangerous. Every one in this room has had an esophageal temperature above 39 degrees if you've ever had a fever or if you've ever had a cup of coffee. That can't possibly be right. It's a limitation of technology.
The Securus technology gives you full 3D resolution of the esophagus, you don't miss any hot points, and it's very quickly responsive to temperature changes. You can pick a much more appropriate temperature cut point, and we think it'll help both then with efficacy and with safety of ablation procedures in the left atrium. If we go to the next slide, I think that's the one that's going to show us the Apama balloon. What you're seeing here actually is an endoscopic view through the Apama balloon, where it's in the ostium of the pulmonary vein. You know that balloon is situated relative to the vein. You're seeing blood flows and gaps either under the electrodes or relevant to the electrodes.
We also, it's a little hard to see in here with the lighting, in addition to the ablation electrodes, there are also diagnostic electrodes embedded in that balloon. You can do the full procedure with that balloon. You don't have to take it out, and you don't have to add a second lasso or any kind of curvilinear catheter to establish whether the ablation worked. Again, as we've said, expecting a CE mark in 2019 and expecting to begin our U.S. IDE, which we've targeted for the first half of 2019. Now, again, just to give you a little more on the Securus probe, just to sort of show you how it works and how different it is from anything that's out there. It uses infrared thermography, gets a very rapid map of where there's heat in the esophagus.
The probe rotates, it just I don't know what the technical word is. It goes up and down. By doing that, you really get a full 3D view of the temperatures in the esophagus. You see here, in the example, if you get one hot spot and you see it as it develops, in this case, the temperature is in the 50 degrees, and likely a physician would choose to come off of RF at that time. It's much easier to use. With the single thermistor probes, you need to constantly go on fluoroscopy and move the probe up and down and back up, and you really don't know if you're matching it to where you're delivering the lesion. We've seen a lot of excitement, particularly the folks who've used this in clinical trials have said they would never, ever go back to using anything different.
Targeting commercialization of that in both the U.S. and Europe first half of next year.
I think the kind of the one bullet point, if you think about Ken's point that if you send a single thermistor down the esophagus, you have to keep that position wherever your ablation catheter is. This system, each second, will have a throw of six centimeters, and it gives you 8,000 temperature points without any involvement of the electrophysiologist or the anesthesiologist. Compared to what is done today in esophageal temperature modeling, this is a pretty significant leap forward. Okay, Ken, new data, however.
We touched on a couple other trials here that we're particularly proud of. Again, nice of Joe to say, but we really do believe we are the leaders in developing the clinical science that really validates that our innovations meaningfully impact patient lives. We talked already about the device-related thrombus latebreaker. Told you that I can't tell you anything about the SMART Pass latebreaker, but we would encourage you to look for that when it comes out. The other big latebreaker, and this is one that we co-funded, I'm sure everyone saw the results of CABANA. Really encouraged by those results. It missed its primary endpoint, but there were some very clear positive signals in the data.
I think we'll have to wait until the full trial is published before we really get a sense of what impact it's going to have overall on the market. At the very least, the data there clearly reinforced the data from trials like CASTLE-AF on the benefits of RF ablation in patients with heart failure. I think again, overall, I think it's going to be a positive impact. I'm not going to run through all the different posters that we show here. There's only one that I would highlight because I think it's really important. Again, it gets back to the core. It's not particularly sexy. It was a trial that we funded through our investigator-initiated trials process done at UPMC by Samir Saba.
What they did was to use their EMR to identify patients who should be defibrillator candidates but who do not have a defibrillator. They actually did a very elegant randomized trial where they randomized sending alerts out to some practices versus not sending alerts out, just going through usual care to other practices, and showed in a randomized trial that sending those alerts out was associated with a 23% increase in referrals to EPs for defibrillators, and there was a strong trend actually in favor of a mortality benefit for the patients whose physicians got alerts. The reason I highlight it is I think it tells you that even in a highly penetrated, mature market like we see for primary prevention ICDs in the United States, there still is underutilization.
There still is a pool of patients that could be tapped and that things like the EMR can actually be used in a positive way to get more patients into the pipeline. The only other thing I will say here, which is a preview of the upcoming European Society of Cardiology heart failure meeting, we do have six different abstracts focusing on different features of HeartLogic and again, making it clear that we are going to continue to advance the science with the HeartLogic heart failure diagnostic and make sure that that gets disseminated to heart failure physicians as well as to EP implanters.
Great. In closure here, obviously, as part of our strategic planning process, we have had the objective of growing operating margins within the rhythms segment for many years. I think as the controller, what I am most proud of is we have been doing that on a short-term and a long-term basis, right? Consistent results now for five, six years. Clearly, we have seen the growth and profitability. We have really doubled our segment margins on what I would call modest top-line growth within rhythm management. I think what is most exciting is if you look at our core businesses, if you start with Core CRM, what you have seen since really the last almost three years is consistent performance above market each period in Core CRM. 2% to 3% in markets that have been flattish over that three-year period of time. Consistent performance on the core.
All of that has been happening, this dreaded replacement curve that we have been talking about for some time, that is behind us now. Now we are in a world where we have closed the major gaps in the core CRM portfolio. We have clear differentiation with things like HeartLogic, and we will have the benefit of replacements, not only in our core business, but also in our S-ICD business, which is a pretty chunky franchise today with very low replacements. As you stepped out on EP, I think you have seen the performance the last three to four quarters, where we have been pushing growth rates up into the teens. Clearly, you have seen the portfolio that has been laid out here today in EP.
As we look to the future, obviously with our reporting change in Q1 with our combined Rhythm and Neuro segment, at this point, we're kind of reconfirming the guidance that Joe would have given at Investor Day, which is about 400 basis points of operating margin growth under the new segment. Put that at least at current currency rates, around 23% in 2020. With that, I think that's the end of prepared remarks, and we're ready for QA.
Bruce Nudell from Centaurus. Two questions, one for Joe. Everybody knows S-ICD is at a premium. As the market migrates to S-ICDs with ATP, can we expect to see that premium maintained across the market? First question. The second one is for Ken. I was in the Reddy session this morning with 4% of the patients had demonstrated thrombus. Some of them were very late. It actually speaks to the But ascertainment wasn't uniform and long. The question is this an underlying fact? 4% of the patients had 14% in strokes. The question is, can thrombus be more common than that? Does that open up opportunities for reducing the stroke rate? What do we expect to see with the warfarin? I know it's at the warfarin level now.
Maybe I'll take that first, because it's actually, it's a really deep question. I think you've hit on where we see this going. I think it's important to point out in terms of, first of all, are there concerns about really late thrombus? The fact of the matter is, we've had five-year follow-up now in both of the randomized trials and in registry studies. We know that there's no acceleration, there's no increase in stroke risk as you go late out. We're pretty comfortable that on ascertain late thrombus is not any kind of major issue that's going to hamper the overall efficacy of the device. I think as you pointed out, we know right now the comparable warfarin, we know we've got 4% device-associated thrombus.
If we can come up with things that knock that device-associated thrombus down to 2% or 1%, what impact does that have? The answer is, that gets us to be better than warfarin. What can we do to do that? There are really two different lines of attack for that. One is modifications to the device itself. I didn't say when I got into FLEX, one of the differentiation features of FLEX is that the area of exposed metal, the screw, is smaller than the area of exposed metal on the current generation of WATCHMAN. We know that many of device-associated thrombuses appear to use exposed metal as the nidus for where the thrombus originates. We're hypothesizing at this point that reducing the area of that metal screw may well reduce the DRC rate.
That's hypothesis, and that we aren't going to know that until we get through a trial like PINNACLE FLX. A second question is whether there's anything we can do in terms of the adjunctive drug regimen that would help reduce the thrombus rate. One of the other exciting features of the FLX device is that that trial is not just a trial of the FLX device. That trial is also our first trial where we're using one of the novel, or actually it's a choice for physicians, any of the novel oral anticoagulants as the immediate post-implant regimen and not warfarin. Also time is going to tell for us whether any of the NOACs are better at avoiding device-associated thrombus than was warfarin.
Back to your first question, Bruce. Over the six years of launch as the only S-ICD around the market, and unless there's a technology that's AV duals and has just more stuff going on inside the device, we did launch it at a significant premium. We have maintained that pricing premium very consistently around the globe. If I look at what's going to happen through the 2020 time frame that we've talked about publicly, I don't really see another subcutaneous ICD coming across the goal line in any major market. By the way, our modular system won't come into the market in that time frame either. I don't believe that's going to be an issue in pricing.
If you said, "Well, what's the theoretical for our S-ICD plus an EMPOWER pacing seed or ATP seed?" You have the S-ICD, which has clearly been marketed as a premium price product. We see one of our competitors launching a leadless pacemaker at a substantial
300%-400% more expensive. I see the patient that received that modular therapy after we do the clinical trials and after we get approved, as being probably a price premium to what we're implying today for ATP.
Joanne. Thank you. Joanne Wuensch from BMO Capital Markets. A couple questions. What is your view of the CABANA trial? The Wall Street Journal seemed to have its own view. You mentioned your modular CRM systems. Could you give us an update on that, please?
Sure. Let me take the second part. It's kind of interesting. I was going to point this out at some point in time, but let me give you a little prelude first. We love the current portfolio we have. I don't believe our commercial portfolio around the world has ever been stronger than it is right now in 2018. If you notice, we have four enormous programs all finishing at the exact same time. We have our force sensing catheter, we have our implantable cardiac monitor, our LUX-Dx, and we have our EMPOWER pacing systems, and I just forgot one.
Apama.
Apama, all finishing development at the end of this year. When we put the timelines for where they're going next, clinical studies, et cetera. EMPOWER, the actual seed of why they're doing single-chamber pacing or RVATP, that development work will be completed late this year, and then next year we'll go into the supportive clinical studies that will be required in key markets around the globe. We'll start those studies in 2019 and finish the development work this year.
CABANA. Everyone, even The Wall Street Journal, is entitled to their own opinion. I'll give you my opinion, but the caveat on that is I think we're really not going to see where things settle out in the community as a whole until the paper's published. Because there's a lot more detail and data than what Doug Packer was able to present in the time allotted to a single late breaker here, and some of that's important data. The rigorous statistician's view, and speaking as a clinical trialist, we've got to leave it at least its primary endpoint. I think behind that, though, I would make three observations. The first is this is a worst possible case trial design in that, remember, enrollment of patients in this trial went on over about eight years.
It really began, and for many years was carried out with technologies that are now considered obsolete, and with strategies for ablation that have subsequently been proven to have limited efficacy. I would tell you with a high degree of probability that every electrophysiologist here, if you ask them, would say that the results if that trial were started today would be better than the results that we got with the trial that was started 8 years ago. The second point is you've got to hate the term negative for a trial. What it really was is a neutral trial. In the intention to treat analysis, it didn't show a proven benefit to ablation, but it likewise didn't show any harm to ablation, even though this was a high-risk group of patients.
It could have gone on and gone into it worrying that adverse events might actually show harm. I think everyone is going to take this as saying, hey, what this shows you is that ablation is at least as effective as drugs, even as a first-line therapy for these high-risk patients. Last, and the one that I come home to is when you start looking deeper into the data, there's some really strong, really positive signals. The one that's most apparent right at the outset, even the intention to treat, is heart failure patients and sort of coming on the heels of CASTLE-AF and the trials that preceded CASTLE-AF. This is going to, at the very least, advance the market for ablation in patients with both heart failure and atrial fibrillation.
Go, Josh. While waiting for Josh, one from the web here. Ken, back on WATCHMAN, physicians are eager to see data versus NOACs, there is a study that this person has seen in Prague comparing WATCHMAN to NOACs. Can you just talk about that and potential timelines or the significance of that trial?
Yeah. I'm of two minds on this. First, I understand people want to see how does it stack up against NOACs. There's this perception out there that NOACs are more effective than warfarin. That's one of the reasons I thought that that trial that DJ McAleery presented today at the late-breaker session that Vivek was at was so important. That actually showed in a large real-world data claims-based survey that those NOACs were not any better than warfarin. In fact, in patients who were poorly adherent, they were actually worse than warfarin. Nevertheless, people ask the question. There are some individual studies or some small multi-center trials that are doing it. We will be commencing a study called OPTION. It's going to be our first trial comparing use of WATCHMAN with these NOACs, and that's going to be in the post-atrial fibrillation ablation population.
We're looking to launch that trial hopefully in 2019. The other point, the reason that the question confuses me a little bit I think we've been very upfront all along in saying, for those patients who are doing well on an oral anticoagulant and we're predictably going to do well on an oral anticoagulant, God bless you, go ahead and take the pills. Where WATCHMAN is useful, it's as an alternative for patients who are high risk, who are eligible for anticoagulation, but who have valid reasons to seek an alternative. When you look at the discontinuation rate of these medications, you look at the number of patients who are just being left unprotected, I know that we have been left unprotected. To me, those are the really important patients to focus on.
Okay. Thank you. Joshua?
Thanks. Congratulations on the progress with Cigna UnitedHealthcare for the sudden cardiac death ICD coverage. I was just wondering, one of the risks we've historically thought about for the sudden cardiac death ICD adoption and growth was the reimbursement level. Our understanding, it's reimbursed the same level as a single-chamber ICD implant, and it's with the premium pricing. If that procedure is not profitable for a hospital, that could limit the growth. Obviously, that has not been the case. You guys have grown. I just wanted to check in and see if that's still the case, and are these procedures profitable? Could you be growing sudden cardiac death ICD or driving deeper penetration with a lower premium price, so that those procedures are actually profitable for hospitals?
You must have talked to Mike Mahoney because I've been asked the same question several times. Hypothetically, I can't answer the price sensitivity, et cetera. I think what has driven this six-year sort of offense with S-ICD is the differentiation of the technology. Keeping leads out of the vasculature, out of the valves. It's just intuitively obvious. We will know in 2020, in that core kind of SCD health Medicare-eligible patient population, how do we do against a transvenous system? So I think we're really excited about that. I'm glad we funded that study. That was an ISR with Reinoud Knops. I'm not going to really speculate, like, what would it be if I were 10% less? I would say the power of the sort of value proposition for S-ICD has not been a huge hindrance.
Reimbursement, conversely, or limited reimbursement in only patients, if you read all of the first wave of private payer reimbursements in the U.S., you would have seen things like no vascular access, previous infection, right? What we're really excited about is now you're seeing major insurers like UnitedHealthcare say, "No, it's the exact same indication," which will take down the actual refusals or the multiple reviews that sometimes you have to go with private pay. We're pretty encouraged by what we see. I'll tell you one other thing, too. If you look at markets where the payer isn't really in the decision-making process, I would put Japan in that category, and I would put many markets in the EU.
We are growing substantially faster than our global 10% double-digit number when it's a clinician that gets to make the sole decision for what is right for that patient. We're making great progress in the U.S. with the private payers. Do you have anything?
Okay. I just want to follow up. The EMR study that was performed by UPMC, it sounds very interesting. What can Boston do to help centers, I guess, bring that data to the real world? I mean, is there anything you will do individually outside of marketing that study? Is there anything you can do within systems, EMRs, to help Boston capture share through that study, et cetera? That'd be interesting to hear. Thanks.
A lot of retail banks, I think, have advanced analytics stuff .
I think this is the promise of the digitization of healthcare data, right? Think of 15 years ago, you had a whole bunch of little folders in endless stacks. That's where your healthcare data was. I think what it does is it gives you a glimpse, and this is not just in EP, but we see it in pharma, the ability to quickly gather data out of an EMR that tells you patients that are being undertreated, overtreated, who've comorbidities, who've not seen a specialist. I think we're just, and this is a great example, we're just scratching the surface on how the digitization of your health records and your health status is going to lead to better and earlier identification of patients at risk for a lot of diseases and, in this particular interest, prevention of sudden cardiac death.
I think the only thing I'd add is, this is at a higher level, again, it's not the tactical how you're going to deal with this for ICD referrals. You can imagine similar things to be used to identify patients who are at high stroke risk, who need some kind of stroke prevention therapy pretty easily. It fits in also when you think back to HeartLogic. This really is, again, using digital technologies to take the burden off of caregivers, but to provide notifications that it's time to do something. It eases workflow, it simplifies work, again, if you look at the example from UPMC, clearly helps lead to better outcomes.
Two more from the web, I think maybe, Joe, I'll take the first one and give the second one to you. First is on the news about a 60 Minutes segment, the second one for you, Joe, is if you can dig into that double-digit ICD growth in Q1. If you can break it out between how much was MRI, HeartLogic, EnduraLife, et cetera. Just quickly first on the 60 Minutes segment, we do believe that 60 Minutes will have a segment this Sunday, the 13th, discussing transvaginal mesh and essentially disparaging its safety and effectiveness in treating women who suffer from stress urinary incontinence and pelvic organ prolapse. We believe there's nothing new in the segment and that all information has previously been publicly disclosed. As a reminder, this has been going on for quite some time.
As you know, we give consistent updates on our first quarter 2018 earnings conference call. We stated that our total legal reserve, of which mesh a portion stood at $1.511 billion. We expect that about $800 million in cash payments will be made this year as we seek to resolve the situation and close it out, we have settled 47,500 out of 49,500 claims, either final, near final, or conditional settlements there. I think just one other thing is that many have chosen to exit this market, we have made the purposeful choice to continue to support our physician customers here who need these therapies to provide options for women with terribly debilitating and embarrassing conditions. This choice has been supported by leading physician societies and task forces such as the American Urogynecologic Society. With that, Joe, back to ICD.
Yes, the question is can we pinpoint this double-digit growth that we saw in Q1, and what would we pinpoint to? I think it's all of the above. If you look at what has driven our offense prior to getting MRI or HeartLogic or multi-site pacing, it was really a few things. Number one, this longevity story that we've been telling since 2008, that has driven a lot of momentum in our transvenous ICDs and CRT-Ds. The phenomenal lead reliability that we have had with our advanced or our tachy leads has been a huge differentiator for our technology. The multi-site pacing, the MRI, that's not new in Europe. That's been driving it for a couple of years now, or a year and a half. They clearly didn't hurt in Q1, where we are the first and only FDA-approved HeartLogic predictive alert.
That drove some of our offense, having finally a 1.5 T tachy MRI approval. That helped. I don't think we can pinpoint it out. We just love the fact that we've had a +10% high-voltage growth globally. I think as you saw one of our competitors report, and we'll see the next one, I think that will be dramatically differentiated from what they put up in Q3.
Sorry, part of the question too was on replacement and not to tease it out perhaps, but perhaps, Mark, you want to comment if this remains on track and what we've guided to in terms of the kind of.
I would say one more thing, probably peel back the onion a little further for Joe. What I was most impressed by in Q1 performance was all of the high-voltage franchises performed very consistently. Whether I look at our transvenous business, I look at our CRT therapy business, I look at our S-ICD business, we really hit across the board, not only in the U.S. but all markets. I would also say, in Q4, you saw acceleration of our high-voltage business with backward labeling. Then we really got on the offense throughout Q4 and clearly going into Q1 on the contracting with Resonate. The acceleration that you see in high-voltage growth is partially driven by the contracting cycle on the Resonate family of devices in the U.S. I think the consistent high-voltage performance is impressive.
On the replacement curve discussion, we've been clearly giving guidance on this for, I don't know, three or four years now for some time. When I look at our replacement cycles, as a reminder, it's been driven by EnduraLife, right? When you launch a battery that lasts roughly three years longer, you have to wait for those devices to come out, right? If I start with the transvenous devices, at this point, we're seeing growth in our CRT replacement curve, exactly as we said we would. Those markets that launched this technology in 2008 with the launch of the COGNIS device are now seeing the replacements come back in the CRT front. On the core ICD side, we're in the trough right now. We're not really talking about it as a headwind. We're not really talking about it as a tailwind.
As we start to move forward about 12 months, we'll start to see more of those devices, particularly in the dual chamber application, come out, and then eventually those single-chamber devices along with S-ICD.
Okay.
What we've said on that, just to remind you, I told you at Analyst Day, that we see replacements driving 100 basis points of differentiated growth in our CRM business through 2020. The last thing, Mark, you might want to comment on this because you're closest to it, but to date, we launched in the UnitedHealthcare States as an example of the S-ICD. What we've actually seen is we've seen an overperformance of that battery technology. We haven't really even began to see S-ICD replacements. Those are not 15-year devices like our single-chamber ICDs.
When we work into the rest of 2018, 2019, 2020, you're also going to see a lot of the momentum that we've had with S-ICD de novo patients who are typically younger than the transvenous ICD patients also needing a replacement in the next two and a half years.
Yeah, what I would say about that is clearly the launch of S-ICD, for all practical purposes, was late 2012 into 2013. We launched that general device for about two years, and that was a battery longevity that was just north of six years. You guys can do the math on that, given the timing of that launch and when those replacements will come. Clearly, our contemporary devices use a leverage on EnduraLife technologies, and they're much closer to nine years.
That would give you some input for your models.
Terrific. I have one quick one, because we're coming up on an hour. Go ahead, Matt.
Sure. Well, if I have to pick one quick one, I guess the last question that I get a lot is just, you touched on WATCHMAN footprint worldwide, sort of competition in Europe, and just love to hear your updated thoughts on how you expect to kind of protect clinically or commercially in the U.S. as more competition reaches the U.S. Should we expect and hope to see some kind of inflection in the market that would help kind of lift off loads?
Yeah, I would start with, because I think, when you think about a technology that came to market with two randomized trials, two large CAP registries, the data you saw from NESTED, Ken talked about the PINNACLE FLX. Leading in clinical science and continuing to push the field is a great way to engage our customers. In the relevant sort of through 2020, right? Our biggest protection mechanism is to get WATCHMAN FLX through its clinical trial and launched. I think we have told people publicly, and if not, this will be the first time. Both Atritech had been working on the next gen WATCHMAN. We inherited that in 2011. We delivered that into a limited market release two years ago. We had sort of six design characteristics improvements that Ken talked about.
We hit a check plus on five of those. We did not achieve the same embolization rate. We have a very well-documented embolization rate of WATCHMAN through those two randomized trials, the CAP and the global post-approval experience that is less than 1%. That is a strict bar that we have to hit. The original design effects did not hit that. We spent two years redesigning it and tweaking it. Obviously, we're super confident that by going into the IDE that we have fixed that problem. We take that sixth design characteristic and hopefully put a check plus on that. That's why we're doing the WATCHMAN FLX IDE.
I think in the relevant sort of when can somebody get into a big market like the U.S., we really like our chances and our timing around the WATCHMAN FLX study and being able to have that as a true second-gen device going up against new market entrants in countries like the U.S. and being able to get into Europe much sooner than what the IDE timeline would be in the U.S. Ken, anything to add?
No.
Great. Joe, Ken, Mark, thank you very much. Thanks again, everybody here. Appreciate your time, and have a good rest of your Friday and HRS.
Thank you.