News | May 12, 2008

Edwards Introduces New Transcatheter Valve Delivery System

May 13, 2008 - Edwards Lifesciences Corp. launched a next-generation transfemoral delivery system for the Edwards SAPIEN transcatheter heart valve designed for transcatheter aortic valve replacement procedures at EuroPCR 2008 in Barcelona, Spain.

The RetroFlex II delivery system retains many of the features of the RetroFlex delivery system, and adds a tapered nose cone that facilitates the passage of the valve delivery catheter over the curve of the aortic arch and through the patient's native, diseased aortic heart valve. The new delivery system is designed to enhance ease-of-use and improve access during the transcatheter aortic valve replacement procedure. European centers will benefit from this new technology during the coming weeks.

"At EuroPCR, we will share clinicians' experiences and insights into achieving a high rate of acute procedural success with the Edwards SAPIEN transcatheter valve, providing other clinical centers with the opportunity to learn from the current experience," said Patrick B. Verguet, Edwards' corporate vice president, Europe. "With more than 1,000 transcatheter heart valve patients worldwide, we look forward to continuing to work closely with clinicians in Europe and offering this technology to more patients."

The first procedures with the new transfemoral delivery system were performed by John Webb, M.D., director of the cath lab and cardiac intervention at St. Paul's Hospital in Vancouver, British Columbia. His multidisciplinary team has performed more than 150 transcatheter aortic valve replacement procedures, including more than 25 utilizing the RetroFlex II delivery system.

"The RetroFlex II delivery system is a big step forward. It is designed to give the physician maximum control when delivering and implanting the transcatheter aortic valve, making it easier to get to and then cross the patient's native valve," said Webb.

Representatives from Edwards will be in the exhibition area at booth F02. The booth features information on Edwards' transcatheter technologies, including the RetroFlex II delivery system, and aortic stenosis, the disease state that necessitates aortic valve replacement. Throughout the entire conference, Edwards will also host hands-on training and education programs on the placement of transcatheter heart valves, with simulators located in the PCR Training Village.

On Thursday, May 15, Edwards will present a symposium, "Establishing a successful transcatheter aortic valve programme" (12:00-13:30, room 3). Chaired by Alain Cribier, M.D., professor of medicine and chief of the department of cardiology at the University Hospital of Rouen, France, and Friedrich-Wilhelm Mohr, M.D., professor of cardiac surgery and medical director of the Heart Center at the University of Leipzig, Germany, the symposium will address what clinicians have learned about patient selection and the importance of a multidisciplinary team approach in a transcatheter valve program.

For more information: www.edwards.com

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