Healthcare Industry News:  Edwards Lifesciences 

Devices Cardiology

 News Release - May 12, 2008

Edwards Lifesciences Introduces New Transcatheter Valve Delivery System at EuroPCR 2008

Scientific Program Highlights: Establishing a Transcatheter Program, MONARC Feasibility Update

IRVINE, Calif. and BARCELONA, Spain, May 12 (HSMN NewsFeed) -- Edwards Lifesciences Corporation (NYSE: EW ), the world leader in the science of heart valves, announced the launch of the company's next-generation transfemoral delivery system for the Edwards SAPIEN transcatheter heart valve 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.

Transcatheter Symposium

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. Cribier performed the first transcatheter aortic valve replacement 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., director of the cardiac catheterization lab at Lund University Hospital, Sweden. His presentation, "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 EVOLUTION feasibility study of the MONARC system, which was conducted in Europe and Canada," said Stanton J. Rowe, Edwards' corporate vice president, advanced technology. "Working in close cooperation with our physician partners, we are committed to moving forward to the phase two study, EVOLUTION II, which will include tracking the clinical outcomes of the participating heart failure patients and ultimately establishing a new therapeutic option. We look forward to providing additional details about the design of EVOLUTION II at scientific conferences later in the year."

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. In 2008, Edwards celebrates 50 years of partnering with clinicians to develop life-saving innovations. The company's global brands, which are sold in approximately 100 countries, include CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at

The Edwards SAPIEN transcatheter heart valve, the RetroFlex delivery system, the RetroFlex II delivery system and the MONARC system are investigational devices and are not available for sale in the United States. The Edwards SAPIEN transcatheter heart valve and the RetroFlex delivery system are being evaluated in a U.S. pivotal clinical trial.

The physicians mentioned in this press release are paid consultants to Edwards Lifesciences.

Edwards, Edwards SAPIEN, RetroFlex and RetroFlex II are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, MONARC, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

Source: Edwards Lifesciences

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