After exploring a number of new product markets to drive growth in the decade since its spin-off from Baxter, Edwards has found its sweet spot in its own backyard: heart valves. Through an aggressive early acquisition, the company has emerged as the leader in what looks to be the next major device product market: - transcatheter valves. But in building a transcatheter valve business, Edwards must maintain its surgical customers while also selling to new physician customers: interventionalist cardiologists - a clinical specialty with a history of competing with surgery.

Heart valve replacement and repair has long been the exclusive province of surgeons. The percutaneous heart valve sector, including both aortic and mitral, has been among the hottest device areas for investors and entrepreneurs over the past few years. CoreValve was founded b a surgeon who is using his understanding of valve anatomy to develop a percutaneous aortic valve replacement (PAVR) device that can be used by interventional cardiologists.

The US FDA has published a raft of guidances on ANDA submissions and labeling updates as well as information requests and discipline review letters.