Edwards Lifesciences Corporation says it is launching the Carpentier-Edwards Physio II mitral valve repair ring, now that the device has won FDA clearance. The annuloplasty ring is already being marketed in Europe.
Edwards says the second generation 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 company says.
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Since the creation of the original Carpentier-Edwards Physio ring, scientific knowledge about mitral valve anatomy and pathology has expanded significantly, and [the new understanding] has been applied in the design of the new Carpentier-Edwards Physio II ring," says Alain F. Carpentier, M.D., Ph.D., professor and chairman emeritus of cardiovascular surgery at the Hopital European Georges Pompidou in Paris, and the inventor of the original Carpentier-Edwards Physio ring.
Carpentier, a 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 Edwards' ring.
"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," says Adams, the Marie-Jose 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.
About Edwards Lifesciences
Edwards Lifesciences is a leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, CA, Edwards treats advanced cardiovascular disease with heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz.
