The FDA’s approval of a trans-catheter heart valve was a landmark achievement in medical device history. There are two current market leaders, Medtronic’s CoreValve and the SAPIEN device by Edwards Lifesciences. But only Edwards’ device is currently FDA-approved in the USA, as of October 2012.
Edwards Lifesciences CEO Mike Mussallem discusses the process of getting the company’s technology through the FDA at the MassDevice Big 100 West in Irvine, California.
