SOURCE: Edwards Lifesciences

Edwards Lifesciences

May 20, 2014 08:10 ET

Early Patient Cases With Fortis Valve Presented at EuroPCR 2014

PARIS, FRANCE--(Marketwired - May 20, 2014) - Edwards Lifesciences Corporation (NYSE: EW), 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.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements made by Dr. Thomas and Mr. Mussallem, and statements about the potential for improvements to the procedure, and the potential benefits of mitral transcatheter valve therapy. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unanticipated results of the clinical experience after more procedures are completed or after longer-term follow up, delays in the clinical trials or product development efforts, or unanticipated decisions by regulatory authorities. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2013.

Edwards, Edwards Lifesciences, the stylized E logo and FORTIS are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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