First Human Implantations Performed With Edwards' Fortis Mitral Transcatheter Valve System

March 6, 2014—Edwards Lifesciences Corporation (Irvine, CA) announced that the first three human implantations of the company’s Fortis mitral transcatheter heart valve were successfully performed via a transapical approach in February and March by the heart team at St. Thomas’ Hospital in London, United Kingdom.

According to the company, the Fortis mitral transcatheter valve is composed of Edwards’ treated bovine pericardial tissue. The device features a cloth-covered, self-expanding frame designed to minimize paravalvular leak and a unique anatomical anchoring system. Edwards advised that the Fortis transcatheter mitral valve device is not for sale in any country.

The heart team at St. Thomas’ Hospital is led by Martyn Thomas, MD, Clinical Director of cardiovascular services, Jane Hancock, MD, consultant cardiologist specializing in imaging, and Vinayak Bapat, MD, consultant cardiothoracic surgeon.

“These first patients had severe mitral valve disease and many risk factors that prevented them from undergoing surgery. After careful evaluation and close consultation with the patients and their families, we determined that this therapy could potentially extend and improve their lives,” Dr. Bapat commented in the company’s press release. “At this early stage, we are very pleased with the initial recoveries of these patients. We’re very proud to play a role in advancing the investigation of this developing therapy, which has the potential to fulfill an unmet need among many patients.”