Highlights from Third Bridge Forum's MedTech Week

In our Edwards Lifesciences – TMTT (Transcatheter Mitral Tricuspid Therapy) Penetration & Innovation Prospects Interview, a former senior manager at Edwards Lifesciences Corp discussed the migration to transcatheter technologies and the competitive landscape, among other topics. Edwards, which focuses on valve repair and replacement, is one of the key players in the cardiac space along with Abbott Laboratories, Boston Scientific Corporation and Medtronic.

Discussing why the company’s Q2 2022 surgical volumes were more resilient than transcatheter aortic valve replacement (TAVR), the expert highlighted that TAVR “has exceptional outcomes” but is “really dependent on being able to have the facilities up and running”. While surgical treatment is still considered by many as the gold standard to treat aortic regurgitation, TAVR is becoming an increasingly important option for higher risk patients. TAVR’s migration to lower risk patient cohorts also represents a significant market opportunity.

On the recent FDA approval of Edwards’ Pascal transcatheter repair system for the treatment of mitral valve regurgitation, the expert said they expect the device to “take off” – matching or even surpassing Abbott Laboratories’ MitraClip. “I think that… the investment that they make in clinical evidence is really going to help them outshine their competitors, and the fact that they have a full portfolio of cardiac solutions is going to work in their favour,” the expert said. 

Also in the Interview they said Edwards is able to maintain its price premiums because it offers “the whole package”. Even as cutting-edge technology becomes more commoditised, they believe the company’s Sapien 3 device is at low risk of ASP price erosion. “There might be some price erosion with some GPO consolidations… but the truth is that Edwards continues to innovate so much and so well.”

Among their closing remarks, the expert said heart failure is “absolutely the next frontier” in structural heart innovation because most technologies today are aimed at acute patients, leaving a significant opportunity to address the needs of chronic patients. “You’re really going to see when the heart failure pieces start coming together, this idea of early identification, earlier intervention, earlier or more frequent monitoring, especially with the prevalence now of monitoring at home,” the specialist said. 

In our Structural Heart Market – TAVR, TMVR & TMTT Procedures – Product Comparative  Analysis & 2023 Growth Trajectory Overview Interview with a former executive at Edwards Lifesciences, we were told that Edwards’ Pascal device could carve out market share of “35-40% within several years” if it keeps improving the device. “I think that the market growth on top of that is going to drive a pretty nice growth for transcatheter mitral tricuspid therapy (TMTT) and, of course, this is not the only thing they have,” the specialist said. There are a number of “excellent trials” in TMTT which seem “very competitive”, they added.

The expert was optimistic on the transcatheter mitral valve repair (TMVR) market opportunity, but noted that adoption is slow. “I’m not sure we’re going to make USD 3bn by 2025, but I think we’ll see very attractive and steady growth.” Market penetration is “pretty good” in Germany, some areas of France and the Netherlands, but lower in Spain and parts of Italy, according to our Interview. 

On Edwards’ Evoque valve, a device designed to replace the tricuspid valve without open-heart surgery, the expert believes it could become a dominant product in the long term. “It seems to be pretty simple to perform and the early feedback I get from physicians and outcomes are very positive, so this could be a segment-leading product for tricuspid for TMTT,” the expert said. However, “anatomically, it’s very challenging”, we were told.

Edwards is also conducting clinical trials around interatrial shunt treatment, which our expert said they are a “big fan” of and expects the V-Wave study to be positive. If trial results are strong, the specialist said approval could be granted in 2024. The specialist added that there are several other technologies worth noting such as ablative therapies to treat pulmonary hypertension or heart failure. “There’s a pretty broad range of therapies that are being developed in this area that I think are going to be fascinating to watch.” 

Forum’s Interview on left atrial appendage closure (LAAC) revealed that the market could grow at a CAGR in the mid-teens. “When more and more data continues to roll out… then potentially the market will expand and all ships will rise,” the former VP at Abbott Laboratories Ltd said. In the meantime, growth is expected to come from therapy expansion and referral activities, as electrophysiologists, interventional cardiologists and hospitals have “mostly already gotten on this train”.

In terms of the competitive landscape, the specialist highlighted a study by Abbott and DJ Lakkireddy which suggested an advantage of 2-5 points to Abbott’s Amulet over Boston’s Watchman device in “pretty much every single category”. Regarding sales force strength, however, the expert is of the view that Watchman’s team is “sharper in terms of experience”. Speculating how market share could evolve, they noted that Boston had an “enormous” head-start but that in the long term Amulet could win the “lion’s share” thanks to its innovation and commercial prowess. But for now, Watchman maintains 60-65% market share, according to our Interview.

In our JenaValve – Core Product Analysis & TAVR  Market Disruption Opportunity Interview we heard that, assuming positive ALIGN-AR trial results, Europe-based JenaValve could commercialise its Trilogy Heart Valve System, which treats AR and aortic stenosis (AS), in 18 months. “One of the things that’s a caveat in all this is aortic regurgitation still is a surgical treatment,” a former senior executive at JenaValve Technology Inc said. They also noted that thoracic surgeons are “very cautious”. Once JenaValve has a fully commercialised and operational platform, the expert estimated that the company’s portfolio could expand into AS, mitral repair, and then tricuspid.

They also said they thought JenaValve could make an attractive line item extension if a medtech behemoth wished to acquire the company. “I know just from the industry talk, there are probably discussions.” In Europe, “probably two or three” players see a positive scope for integration with JenaValve, we were told. 

In Forum’s Boston Scientific – Cardiovascular Portfolio Analysis & Outlook Interview, a former VP at Boston Scientific Corp said core interventional cardiology devices are “quickly becoming commoditised” and “some of the more specialised devices are leaning that way as well”. US drug-eluting stent growth is in decline and “keeps going lower”, they said. Relying on international growth is “risky”, they added, but “whoever can figure it out the fastest is going to take the day”.  

In a comparative analysis of Boston’s Watchman FLX versus Abbot’s Amplatzer Amulet, they posited that Amulet has a “high-single-digit to low-double-digit share at this point”. Some of that is trialling that does not necessarily turn into permanent utilisation, they added. Overall, Watchman, the expert believes, is “incrementally better than the Amulet platform”, having been designed specifically for left atrial appendage occlusion. However, there is a subset of patients for which Amulet “might be more appropriate”.

We also heard about Boston’s February 2022 acquisition of Baylis Medical, which provides advanced transseptal access solutions. The specialist said they understand it has been a success, particularly from a technology strategy perspective. “I think it also just demonstrates how serious they are about growth in that market.”

To view these insights in greater detail – and more – click on the transcripts below.