Transcatheter mitral valve replacement therapy has yet to prove itself clinically, but it emerged this year as the next frontier for structural heart innovation and rapid deal-making.

Edwards Lifesciences bought Irvine, CA-based CardiAQ for about $400 million. Abbott made two deals even as it has its own FDA-approved MitraClip repair device. It bought Roseville, MN-based Tendyne, for $250 million in addition to undisclosed milestone payments and separately invested an undisclosed sum in San Jose, CA-based Cephea Valve Technologies, securing an option to buy it outright later. Medtronic spent $458 million to buy Redwood City, CA-based Twelve Inc. to jump on the TMVR bandwagon, and Canadian startup Neovasc is also developing a TMVR product.

In the United States, 7 million people—about 2% of the population—suffer from mitral regurgitation, according to Joanne Wuensch, a BMO Capital Markets analyst. Roughly the same number are afflicted in Europe. This group includes 4.1 million people who have moderate to severe mitral regurgitation. The number of new patients added each year is 250,000. In other words, the opportunity is huge. 

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[image courtesy of EDWARDS LIFESCIENCES]

Start 2016 off right by attending MD&M West, the world's largest medical design and manufacturing event, February 9-11, at the Anaheim Convention Center.