The past year 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. (See Also see "Cardiac Rhythm Management Market Faces Continued Challenges Ahead" - Medtech Insight, 1 August, 2011..) 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 markets outside the US, where some 50,000 patients have undergone the procedure to date