Early Humanitarian-Use Procedures With Edwards' Fortis Mitral Valve Reviewed

May 20, 2014—Edwards Lifesciences announced that details about the first-in-human experience with the company’s Fortis mitral transcatheter heart valve were presented at the EuroPCR 2014 congress being held in May 20–23, in Paris, France. During the EuroPCR late-breaking session on transcatheter mitral therapies, Vinayak Bapat, MD, a consultant cardiothoracic surgeon at St. Thomas’ Hospital in London, United Kingdom, and Martyn Thomas, MD, Clinical Director of Cardiovascular Services at St. Thomas’ Hospital, reviewed the first patient cases performed at their hospital and Inselspital in Bern, Switzerland.

According to the company, all of these patients had severe mitral regurgitation, marked breathlessness, and multiple comorbidities. They were not candidates for surgical mitral valve intervention. Medical teams were granted access to the Fortis valve, which is not for sale in any country, on humanitarian/compassionate grounds.

The medical teams reported that of the first four cases with the Fortis valve, three patients died between 4 and 76 days after the procedure. One patient continued to be followed at 76 days. A fifth patient was treated at St. Michael’s Hospital in Toronto, Canada, the week before the EuroPCR presentation, and that 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 postoperative management.

In the company’s press release, Dr. Thomas commented, “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. 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.”

Michael A. Mussallem, Chairman and CEO of Edwards Lifesciences, stated, “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. We are confident that our commitment to addressing the unmet needs of patients will lead to transcatheter mitral valve replacement becoming a meaningful therapy."