IRVINE, Calif., May 30 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , the world leader in heart valve technologies, announced today that clinicians have completed 20 patient cases in a U.S. feasibility study evaluating the company’s Cribier-Edwards percutaneous aortic heart valve. Edwards also announced that the U.S. Food and Drug Administration (FDA) has approved expanding enrollment of its U.S. feasibility trial by an additional 35 patients.
“We’re pleased to receive FDA approval to continue feasibility cases to treat additional patients with this important new technology,” said Stanton Rowe, president of Edwards’ percutaneous valve initiatives. “We continue to believe that percutaneous therapies provide tremendous therapeutic potential, particularly for patients who are unable to receive treatment today.”
The Cribier-Edwards percutaneous aortic heart valve is a balloon-mounted, compressed tissue heart valve that can be threaded through the patient’s circulatory system from the leg directly over the aortic valve. The non-randomized feasibility study was initiated in January 2006, after Edwards received conditional approval from the FDA to proceed with its Investigational Device Exemption.
The three institutions participating in the feasibility study are William Beaumont Hospital, Royal Oak, Mich.; New York-Presbyterian/Columbia University Medical Center, New York, N.Y.; and The Cleveland Clinic Foundation, Cleveland, Ohio. Edwards is actively working with the FDA to finalize the eventual pivotal trial design while continuing to collect follow-up data on the feasibility cohort. Percutaneous heart valve cases also are continuing at multiple clinical sites in Europe and Canada in pursuit of CE Mark approval.
About Percutaneous heart Valve Replacement
The Cribier-Edwards percutaneous aortic heart valve is a proprietary technology designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood flow) who are considered to be too high risk to tolerate conventional open-heart valve replacement surgery. The device integrates balloon-expandable stent technology with a replacement tissue heart valve that is compressed onto the balloon to the approximate diameter of a pencil. The therapy was developed in conjunction with Prof. Alain Cribier, M.D., chief of cardiology at the University Hospital in Rouen, France.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company’s global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.edwards.com.
Edwards Lifesciences, Edwards, FloTrac, Magna and ThermaFix are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, PERIMOUNT, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to the ability to feasibility trials and other risks detailed in the company’s filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
Edwards Lifesciences Corporation
CONTACT: Media, Jared B. Adams, +1-949-250-5070, or Investors, David K.Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation
Web site: http://www.edwards.com//
