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Edwards Lifesciences Introduces New Transcatheter Valve Delivery System at EuroPCR 2008

Tuesday, May 13, 2008 General News
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IRVINE, Calif. and BARCELONA, Spain, May 12 Edwards Lifesciences Corporation (NYSE: EW), the world leader in the scienceof heart valves, announced the launch of the company's next-generationtransfemoral delivery system for the Edwards SAPIEN transcatheter heart valveat EuroPCR 2008 in Barcelona, Spain.
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The RetroFlex II delivery system retains many of the features of theRetroFlex delivery system, and adds a tapered nose cone that facilitates thepassage of the valve delivery catheter over the curve of the aortic arch andthrough the patient's native, diseased aortic heart valve. The new deliverysystem is designed to enhance ease-of-use and improve access during thetranscatheter aortic valve replacement procedure. European centers willbenefit from this new technology during the coming weeks.
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"At EuroPCR, we will share clinicians' experiences and insights intoachieving a high rate of acute procedural success with the Edwards SAPIENtranscatheter valve, providing other clinical centers with the opportunity tolearn from the current experience," said Patrick B. Verguet, Edwards'corporate vice president, Europe. "With more than 1,000 transcatheter heartvalve patients worldwide, we look forward to continuing to work closely withclinicians in Europe and offering this technology to more patients."

The first procedures with the new transfemoral delivery system wereperformed by John Webb, M.D., director of the cath lab and cardiacintervention at St. Paul's Hospital in Vancouver, British Columbia. Hismultidisciplinary team has performed more than 150 transcatheter aortic valvereplacement procedures, including more than 25 utilizing the RetroFlex IIdelivery system.

"The RetroFlex II delivery system is a big step forward. It is designedto give the physician maximum control when delivering and implanting thetranscatheter aortic valve, making it easier to get to and then cross thepatient'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 diseasestate that necessitates aortic valve replacement. Throughout the entireconference, Edwards will also host hands-on training and education programs onthe placement of transcatheter heart valves, with simulators located in thePCR Training Village.

Transcatheter Symposium

On Thursday, May 15, Edwards will present a symposium, "Establishing asuccessful transcatheter aortic valve programme" (12:00-13:30, room 3).Chaired by Alain Cribier, M.D., professor of medicine and chief of thedepartment of cardiology at the University Hospital of Rouen, France, andFriedrich-Wilhelm Mohr, M.D., professor of cardiac surgery and medicaldirector of the Heart Center at the University of Leipzig, Germany, thesymposium will address what clinicians have learned about patient selectionand the importance of a multidisciplinary team approach in a transcathetervalve program. Cribier performed the first transcatheter aortic valvereplacement in April 2002.

MONARC Feasibility Study Update

One year follow-up data from the EVOLUTION feasibility study of Edwards'MONARC system will be provided at EuroPCR by Jan Harnek, M.D., Ph.D., directorof the cardiac catheterization lab at Lund University Hospital, Sweden. Hispresentation, "Percutaneous mitral valve repair: coronary sinus annuloplasty,"will take place during the session, "Patients with mitral regurgitation:balanced judgment based on knowledge and experience," on Wednesday, May 14(13:30-16:30, room 3).

"We are encouraged by the early signs of efficacy from the EVOLUTIONfeasibility study of the MONARC system, which was conducted in Europe andCanada," said Stanton J. Rowe, Edwards' corporate vice president, advancedtechnology. "Working in close cooperat
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