Edwards Lifesciences was first to commercialize transcatheter aortic valve replacement (TAVR) technology, and the Irvine, CA-based company has maintained its leading position in the market. This year it won CE Mark and FDA approval for expanded use of its third-generation Sapien 3 valve in intermediate risk patients and an IDE to study its technology in low-risk patients is in the process.
What’s more, the company could repeat its TAVR success in another arena. It’s also part of the lead pack competing to bring a transcatheter mitral valve replacement system to market.
Edwards was recently named 2016 Medtech Company of the Year by our sister site, MD+DI.