Edwards SAPIEN XT Valve Receives FDA Approval For Aortic Valve-In-Valve Procedures

IRVINE, Calif., Oct. 15, 2015 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received U.S. Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards SAPIEN XT transcatheter heart valve.

"U.S. approval of the valve-in-valve procedure provides an important minimally invasive treatment option for patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valves," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. 

Today, at the 27^th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in San Francisco, one-year patient outcomes were presented for patients treated with transcatheter SAPIEN XT valve implantation in surgical tissue valves. The valve-in-valve procedure was associated with a high overall one-year survival rate of 86.6 percent and a low overall stroke rate of 3.7 percent in a very high-risk patient population, according to independently adjudicated data from the 197-patient PARTNER II Valve-in-Valve study. The study, which is a multicenter, non-randomized cohort of The PARTNER II Trial, included 97 patients enrolled in the primary registry as well as 100 continued access patients.

"We were very pleased to see 100 percent survival at 30 days with the 100 high-risk patients treated with the SAPIEN XT valve-in-valve procedure in the continued access registry," said Danny Dvir, M.D., interventional cardiologist at the Center for Heart Valve Innovation at St. Paul's Hospital, Vancouver, who presented the data. "This is quite remarkable and supports transcatheter aortic valve-in-valve replacement with the SAPIEN XT valve as a safe therapeutic alternative to reoperation for patients in need of a subsequent tissue valve replacement."

The Edwards SAPIEN XT valve was approved by the FDA in June 2014 for patients at high risk for native aortic valve replacement surgery, and received CE Mark for valve-in-valve procedures in early 2014. The SAPIEN valve platform has been used in the treatment of more than 100,000 patients worldwide.

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 Mr. Wood and Dr. Dvir and statements regarding the potential need for, and features and benefits of, the use of SAPIEN XT for valve-in-valve procedures.  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 outcomes following longer term clinical experience; unexpected changes related to product supply; potentials for unexpected regulatory or quality developments; and changes in competitive dynamics, global economic conditions or customer acceptance. 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, 2014.  These filings, along with important safety information about our products, may be found at www.edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, PARTNER, PARTNER II, SAPIEN and SAPIEN XT are trademarks of Edwards Lifesciences Corporation.  All other trademarks are the property of their respective owners.

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SOURCE Edwards Lifesciences Corporation

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