Percutaneous Mitral Valve Therapy: The Next Decade

Article preview from Start-Up - February, 2012

After more than a decade, the field of transcatheter mitral valve therapy is still in its infancy, yet it is surprisingly crowded. The first percutaneous mitral valve company was founded in 1999, the same year that the first transcatheter aortic valve implantation (TAVI) company was founded, but while TAVI is now on the market in Europe and in the US, the leading transcatheter mitral valve therapy has only just completed clinical trials. The anatomy of the mitral valve is much more complex than its aortic counterpart, patients with mitral valve disease make up a heterogeneous group, and the anatomical environment for mitral valve implants is much more challenging.

Percutaneous Mitral Valve Therapy: The Next Decade

Article preview from Start-Up - February, 2012

The year that just ended witnessed two milestones in structural heart disease: the first US approval of a transcatheter aortic heart valve – the Sapien valve from Edwards Lifesciences Corp. – and the completion of the first ever randomized clinical trial for a percutaneous device for mitral valve disease, the MitraClip from Abbott Laboratories Inc.

These two events are heartening for a cardiovascular industry looking for structural heart disease to provide the next major growth opportunities, particularly because revenues from the largest existing cardiovascular markets are flat: drug-eluting stents have leveled off and cardiac rhythm management is in the doldrums. The giant strategics in cardiovascular disease need billion-dollar products to maintain growth, and they’re looking to transcatheter heart valve treatments to provide them. Transcatheter aortic valve implantation (TAVI) is already yielding almost $700 million in revenues (in OUS markets) where some 50,000 patients have undergone the procedure to date. Market estimates place the size of the TAVI market at almost $2 billion by 2014, including only high risk patients not eligible for open heart surgery. The market for percutaneous mitral valve repair or replacement is much more complex, segmenting into different types of disease and different types of treatments. That market is at a very early stage and estimates are that it will hit $1.2 billion by 2014, but its ultimate potential is at least four times greater than the aortic valve market.

Both product segments – transcatheter aortic and mitral heart valves – are on the upswing. However, the positive news comes much later than pioneers in the field ever thought it would, going back to the first companies founded in 1999 – aortic valve company Percutaneous Valve Technologies (bought by Edwards in 2003 for $125 million in cash and Evalve, developer of the first percutaneous product for mitral valve repair, part of Abbott Laboratories since 2009 when Abbott paid $320 million to gain Evalve and its MitraClip.

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