Edwards Lifesciences Corporation Announces First Human Implants With Mitral Transcatheter Valve System

IRVINE, CA--(Marketwired - March 06, 2014) - 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.

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 www.edwards.com.

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. Bapat and Mr. Mussallem, and the potential timing and outcomes of the early clinical experiences with the mitral transcatheter valve, and any potential benefits the valve could provide. 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.