IRVINE, Calif. and BARCELONA, Spain, May 12, 2008 --
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
http://www.edwards.com.
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.
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