There are No Unicorns in Structural Heart

Our firm just returned from the PCR Show in Paris. We have been attending this show for many years. It is interesting to see how markets develop in the medical device space. Historically, the interventional cardiology world has a new technology hit the market and it becomes the “silver bullet” disrupting all other existing solutions. Historically, it has a technology or product family that is hot in early years, suddenly seem to trend towards a commodity in the following years. Think angioplasty balloon, to bare metal stent, to radiated stent, to drug eluding stent, etc.

A decade ago, it was safe to assume the solutions in the structural heart market would follow the same path. Technologies were developed and as typically occurs, sides were picked. Acquisitions started to occur and parties were thrown for the winners and eulogies were being written for the “losers”.

It appears though that due to the complexity of the market, a platform approach of multiple technologies makes sense.

When we look at Structural Heart and the valve space specifically, it is important to realize that each valve is a completely different animal that requires a different treatment paradigm. For example, the Aortic Valve is at the end of a large tube called the Aorta. It is relatively easy to access with a large delivery device, calcification often provides a sturdy bed for implant delivery and full replacement of the Aortic Valve is well tolerated by the heart and the surrounding anatomy. Simple plumbing solution. These and certain other factors have allowed TAVR to become the silver bullet approach for the treatment of AS. In other words, one type of device can suffice. Did this mentality set the stage for all the other valves? 

The incredible success of TAVR as a definitive therapy for Aortic Stenosis indeed may have created a mindset that this “silver bullet” approach to therapy could also work for the Mitral. Back in 2015, Transcatheter Mitral Replacement was all the rage, whereas Transcatheter Mitral Repair was supposedly on the road to obsolescence. Now here we are in 2018 with Transcatheter Repair sales (predominantly Mitraclip) as strong as ever and the Replacement approach experiencing bumps in the road (e.g., LVOT obstruction, general deliverability) on the way to approval. It is not that one of these approaches will absolutely win or absolutely lose. Both can win. The point is that there is no “silver bullet” in Mitral. It is a much more complex anatomy, much more difficult to access, and implants are less well tolerated by the heart and its surroundings. Therefore the strategics will likely need a multi-solutions platform to adequately address this valve. 

It appears though that due to the complexity of the market, a platform approach of multiple technologies makes sense.

The new hot thing in Structural Heart is Transcatheter Treatment of the Tricuspid Valve for Tricuspid Regurgitation and again, some are looking to apply a “silver bullet” paradigm. Not going to happen. The Tricuspid Valve sits on the right side of the heart which happens to be 80% less muscular (imagine, the tissue is 80% thinner) than the left side of the heart, where the Aortic and Mitral Valves reside. This valve will require a lighter touch and be much more challenging for the larger implants (e.g., when surgeons treat the Tricuspid, they use repair and specifically annuloplasty 90% of the time) . The leaflet configuration is also more complex; there are 3 of them. That means more coaptation surfaces, more areas that can leak and therefore more areas to repair. In addition, 1 out of 3 Tricuspid patients in the US have a pacing lead running through the valve.  There are a lot of different situations to treat, but also a lot of patients (~2.5 million in the US) and no gold standard of care to compete with. Similar to Mitral, the strategics will need a multi-solutions platform to address the Tricuspid Valve. Many of them designed specifically for the Tricuspid anatomy. In many cases a single device will work for a specific patient. But in other cases, devices will need to work together (e.g., Trialign with follow on MitraClip) for the optimum outcome, and that’s ok. The most important aspects will be safety (no penalty associated with using the device) and the ability to leave future clinical options on the table. That is what will define a “front-line solution” and it is a front-line solution that will ultimately become the leader in a multi-solution world.