January 26, 2009 - Edwards Lifesciences Corp. today launched 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 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 Hôpital 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 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-Josée and Henry R. Kravis Professor and chairman of the department of cardiothoracic surgery at Mount Sinai Medical Center. Adams and Carpentier are advisers to and receive royalty payments from Edwards Lifesciences.
Edwards received 510(k) clearance from the FDA 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.
For more information: www.edwards.com