IRVINE, CA, January 26, 2009 -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced that the company is launching the Carpentier-Edwards Physio II mitral valve repair ring at the 45th annual meeting of the Society of Thoracic Surgeons (STS) in San Francisco. The new therapy represents the next generation of the Carpentier-Edwards Physio ring, the global market-leading heart valve repair device.
"Since the creation of the original Carpentier-Edwards Physio ring, scientific knowledge about mitral valve anatomy and pathology has expanded significantly, and these new learnings have been applied in the design of the new Carpentier-Edwards Physio II ring," said Alain F. Carpentier, M.D., Ph.D., Professor and Chairman Emeritus of Cardiovascular Surgery at the Hospital Europeen Georges Pompidou in Paris, and the inventor of the original Carpentier-Edwards Physio ring. Carpentier, the foremost pioneer in the field of heart valve repair for more than 40 years, and David H. Adams, M.D., one of the leading mitral repair authorities in the world, are the co-inventors of the next-generation ring.
The Carpentier-Edwards Physio II ring is a novel mitral valve repair solution. It is the only annuloplasty ring offering "shape optimization," which matches the geometry of the ring to the characteristics of the patient's diseased mitral valve, and does not limit repair options based on etiology, or cause, of the mitral valve disease. Several new features, such as a unique sewing cuff, provide surgeons with a device that is also easier to implant.
"The Carpentier-Edwards Physio II ring represents a paradigm shift in our thinking about ring geometry and I believe it is going to result in a higher quality of valve repair in the majority of patients suffering from mitral valve disease," said Adams, the Marie-Josee and Henry R. Kravis Professor and Chairman of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center. Adams and Carpentier are advisers to and receive royalty payments from Edwards Lifesciences.
"We are proud to have a long tradition of supporting surgeons with devices to facilitate mitral valve repair. Our commitment to update the Carpentier-Edwards Physio ring, despite its status as the most widely used mitral repair device in the world, underscores Edwards' dedication to provide innovative solutions and advanced technology for the treatment of heart valve disease," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy.
Edwards received 510(k) clearance from the U.S. Food and Drug Administration to market the Carpentier-Edwards Physio II ring. It will also be available in Europe, as the company has also received CE Mark approval for European sales of the device.
Dr. Adams is the co-inventor of the Edwards Lifesciences' Carpentier-McCarthy-Adams IMR ETlogix Annuloplasty Ring and Carpentier-Edwards Physio II ring. Icahn School of Medicine at Mount Sinai receives royalties from Edwards Lifesciences in connection with the sale of this product, but does not receive any royalties when the devices are implanted in patients at Mount Sinai.
Dr. Adams is the inventor of the Medtronic Tri-Ad™ Adams Tricuspid Annuloplasty Ring. Icahn School of Medicine at Mount Sinai receives royalties from Medtronic in connection with the sale of this product, but does not receive any royalties when the device is implanted in patients at Mount Sinai. Dr. Adams is also National Co-Principal Investigator of the FDA Medtronic-CoreValve Pivotal Trial and National Co-Principal Investigator of the FDA Medtronic APOLLO Pivotral Trial, designed to evaluate the Intrepid TMVR System.