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 company said.
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.
Donald Bobo, Jr, corporate vice president of heart valve therapy at Edwards, said: 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’s dedication to provide innovative solutions and advanced technology for the treatment of heart valve disease.