Edwards' Cardioband Tricuspid System Granted CE Mark Approval
April 30, 2018—Edwards Lifesciences announced that it has received European CE Mark approval for its Cardioband tricuspid valve reconstruction system for the treatment of tricuspid regurgitation.
Approval of the device was supported by the clinical results of the TRI-REPAIR CE Mark study. The company advised that data on the Cardioband tricuspid system will be presented at the EuroPCR 2018 conference, held May 22–25 in Paris, France.
According to the company, the Cardioband tricuspid system is delivered via a transfemoral approach and is designed to reduce tricuspid regurgitation through annular reduction. The device enables precise positioning to a patient's specific anatomy and real-time adjustment with simultaneous confirmation of results. It is the same design and implantation technique that is used for the Cardioband mitral system.
Edwards acquired the Cardioband system from Valtech Cardio in January 2017. The Cardioband system is not approved for commercial sale in the United States.
In the company's announcement, Professor Georg Nickenig, MD, commented, "Although open heart surgical valve repair is practiced today, it has not been performed frequently for those suffering from tricuspid regurgitation, despite evidence of increased mortality in these patients. Now with the European approval of the Cardioband tricuspid system as the first transcatheter tricuspid therapy, patients can have access to a minimally invasive treatment designed to reduce tricuspid regurgitation and improve their symptoms and quality of life." Prof. Nickenig is Chief, Department of Cardiology, University Hospital in Bonn, Germany.