Edwards Lifesciences announces first human implants with mitral transcatheter valve system

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced the successful completion of the first three human implants of its FORTIS mitral transcatheter heart valve, which were performed in February and March by the Heart Team at St. Thomas' Hospital in London.

"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. At this early stage, we are very pleased with the initial recoveries of these patients," said Vinayak "Vinnie" Bapat, FRCS CTh, consultant cardiothoracic surgeon, St. Thomas' Hospital in London. "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." Bapat and the hospital's Heart Team -- also led by Martyn Thomas, MD, FRCP, clinical director of cardiovascular services, and Jane Hancock, MD, PhD, MRCP, consultant cardiologist specializing in imaging -- are experienced in less invasive valve procedures, including transcatheter aortic valve replacement (TAVR).

The FORTIS transcatheter mitral valve features Edwards' most advanced, treated bovine pericardial tissue. It features a cloth-covered self-expanding frame designed to minimize paravalvular leak, and a unique anatomical anchoring system. This series of implants is being performed via a transapical approach to allow direct surgical access to the mitral valve complex.

"We believe mitral valve disease is undertreated worldwide, and there is a particular need among patients who are too high risk to benefit from traditional surgical options," said Michael A. Mussallem, Edwards' chairman and CEO. "We'd like to thank the Heart Team at St. Thomas' Hospital for their dedication to providing outstanding patient care to these patients who faced dismal prognoses and otherwise would have gone untreated. This early experience provides a very important opportunity for learning in this challenging anatomy. Although durable success will not be known without significantly more experience and longer term follow up, we are excited about this potential opportunity that we believe may be very meaningful for patients."

Edwards expects these cases to be reviewed in the normal course at future medical meetings. The company's transcatheter mitral valve, which utilizes a transapical approach that a surgeon performs through a small incision in the ribs, is not for sale in any country.