PARIS, FRANCE, -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that details about the first-in-human experience with Edwards' FORTIS mitral transcatheter heart valve were presented at EuroPCR 2014 during the congress' late-breaking session on transcatheter mitral therapies.

Vinayak "Vinnie" Bapat, FRCS CTh, consultant cardiothoracic surgeon, St. Thomas' Hospital in London, and Martyn Thomas, MD, FRCP, clinical director of cardiovascular services, St. Thomas' Hospital, reviewed the first patient cases performed at their hospital and Inselspital in Bern, Switzerland.

All of these patients had severe mitral regurgitation, marked breathlessness, suffered from multiple co-morbidities and were not candidates for surgical mitral valve intervention. Their medical teams were granted access to the FORTIS device on humanitarian/compassionate grounds. It was reported that, of the first four cases with the FORTIS valve, three patients passed away between days 4 and 76 post-procedure. One patient continued to be followed at 76 days. A fifth patient was treated at St. Michael's Hospital in Toronto, Canada, last week, and the patient is recovering. Additional details about that case were not available for the presentation. The physicians concluded that ongoing work will establish optimal patient selection, procedural steps and post-operative management.

"Clinicians know there are many patients suffering from mitral valve disease who are too high risk to benefit from traditional surgical options. Although these early patient outcomes have been disappointing, we demonstrated that this valve can be successfully implanted and functions as intended," said Dr. Thomas. "The mitral valve and the mitral patient are complex. This journey is going to be difficult, but I believe that this therapy should be pursued and will lead to improved patient care." Dr. Thomas is a paid consultant to Edwards.

"We are grateful for the Heart Teams that guided the first-in-human implants with compassion and deep clinical experience. Similar to the early days with transcatheter aortic valves, we know developing transformational therapies is challenging," said Michael A. Mussallem, Edwards' chairman and CEO. "We are confident that our commitment to addressing the unmet needs of patients will lead to transcatheter mitral valve replacement becoming a meaningful therapy."

The FORTIS valve is not for sale in any country.

Source: Edwards LifeSciences Corporation