IRVINE, CA, February 16, 2012 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark in Europe for its EDWARDS INTUITY Valve System for use in patients undergoing surgical aortic valve replacement (AVR). The system, which consists of a bovine pericardial heart valve and novel delivery system, facilitates small incision surgery and rapid valve deployment during AVR procedures. The company plans to begin a disciplined European launch at centers participating in post-approval clinical studies.
"Minimally invasive therapies are increasingly being sought by patients because of their demonstrated benefits, and the EDWARDS INTUITY Valve System allows us to provide small incision aortic valve replacement with a proven valve platform," said Prof. Michael Borger, M.D., Ph.D., associate director of the Department of Cardiac Surgery at the Leipzig Heart Center in Germany and investigator in the TRITON study, which evaluated the feasibility, safety and performance of the EDWARDS INTUITY Valve System. "This system includes unique features designed to facilitate a faster and more efficient procedure, so physicians have the opportunity to provide patients a desired therapeutic option without added procedural complexity."
The EDWARDS INTUITY Valve System leverages the design of Edwards' pericardial valve technology, which is based on the company's nearly 30-year leadership in tissue valve design. The valve features an innovative balloon-expandable frame designed to facilitate rapid and secure annular placement intended to reduce overall procedural time. The novel delivery system is designed to enable control, accuracy and simplicity throughout implantation.
"This system was developed with key insights and learnings from leading surgeons, and demonstrates our commitment to continued innovation in surgical heart valve therapy," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "We are excited about the promise of this technology to advance the current standard of care for clinicians and their patients."
The EDWARDS INTUITY Valve System is not yet available for sale or use in the United States.
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 that enable 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, Dr. Borger and Mr. Bobo's statements and statements regarding the launch and estimated roll-out of the EDWARDS INTUITY Valve System, design features and expected product benefits and procedural outcomes. 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 the roll-out and benefits of the technology to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to expanded clinical experience, unexpected changes or delays related to product supply, quality and availability, changes in product indications or regulatory decisions. 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, 2010.
Edwards, Edwards Lifesciences, the stylized E logo, and EDWARDS INTUITY are trademarks of Edwards Lifesciences Corporation.
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