IRVINE, Calif., Dec. 1 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , the world leader in heart valve technologies, announced today it has received conditional approval from the U.S. Food and Drug Administration (FDA) to enroll 20 patients in a non-randomized feasibility trial of its Cribier-Edwards percutaneous aortic heart valve.
The restarted trial, which will take place at three clinical sites, will now include a new retrograde delivery system and an additional, larger sized, 26 mm replacement heart valve. The advanced retrograde delivery system provides a simpler route for introducing the valve non-surgically, threading it through the patient’s circulatory system from the leg directly to their aortic valve. Cases are expected to resume upon investigational review board approval, and the completion of clinician training with the new delivery system. As previously announced, Edwards enacted a voluntary suspension of its percutaneous aortic heart valve trial in June of this year.
“We are eager to resume this important trial, and are looking forward to treating the many patients who have been referred and qualify for this investigation,” said William O’Neill, M.D., chief of cardiology at William Beaumont Hospital in Royal Oak, Michigan, and the study’s principal investigator.
Upon successful completion of the feasibility study, Edwards will work closely with the FDA to determine next steps in support of a U.S. approval. In Europe, where a multi-center CE mark study has been initiated, the new retrograde system and larger valve are being introduced on a site-by-site basis.
About the Cribier-Edwards Percutaneous Aortic Heart Valve
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 not good candidates for 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. Unlike conventional open-heart valve replacement surgery, percutaneous heart valve replacement can be performed without opening the chest and under local anesthesia. The therapy was developed 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, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.edwards.com.
This news release includes forward-looking statements that involve risks and uncertainties including those related to the ability of Edwards to satisfy the conditions of, and restart, the percutaneous heart valve feasibility study; the ability to successfully complete the feasibility study and work closely with the FDA to determine the next steps in support of a U.S. approval; 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 they are inherently uncertain and difficult to predict. Actual results or experience could differ materially from that expressed or implied by forward-looking statements.
Edwards and Cribier-Edwards are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT, 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 and is registered in the U.S. Patent and Trademark Office.
Edwards Lifesciences Corporation
CONTACT: Media, Barry R. Liden, +1-949-250-5070, or Investor, David K.Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation
Web site: http://www.edwards.com/
