First Human Implants of Edwards’ FORTIS Mitral Transcatheter Valve

Edwards Lifesciences Corporation has 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.

Background

Mitral valve disease is climbing the leaderboard of conditions which now look treatable, but for which there was only recently no solution for severely sick patients. The starting point was to make approaching the mitral valve a minimally invasive affair. And now a range of options that promise percutaneous or transcatheter treatment of the valve leaflets, the chordae tendinae or the entire valve, are all becoming viable. One such is Edwards’ FORTIS transcatheter mitral valve which features the company’s most advanced, treated bovine pericardial tissue. Its cloth-covered self-expanding frame is designed to minimize paravalvular leak, and it also possesses 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.

The FORTIS transcatheter mitral valve is not approved for sale in any country.

Physician comments

“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).

Company comments

“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.”

Source: Edwards Lifesciences Corporation

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