May 1, 2018 — Edwards Lifesciences Corp.announced that it received CE Mark for the Edwards Cardioband Tricuspid Valve Reconstruction System for the treatment of tricuspid regurgitation. The Cardioband Tricuspid System is the first commercially available transcatheter therapy for the treatment of tricuspid heart valve disease.
"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," said Prof. Georg Nickenig, chief, Department of Cardiology, University Hospital, Bonn, Germany. "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."
The Cardioband Tricuspid System is delivered via a transfemoral approach and is designed to reduce tricuspid regurgitation through annular reduction. It enables precise positioning to a patient's specific anatomy and real-time adjustment with simultaneous confirmation of results. It is the same design and implant technique as is used for the Cardioband Mitral System.
Data on the Cardioband Tricuspid System will be presented at EuroPCR 2018, May 22-25 in Paris, france. The Cardioband System is not approved for commercial sale in the United States.
Edwards acquired the Cardioband System from Valtech Cardio in January 2017, and the receipt of the CE Mark is one of the pre-specified milestones that prompts a distribution of cash and stock totaling approximately $50 million to the former investors of Valtech Cardio.
Prof. Nickenig has received compensation from Edwards for educational and training activities.
For more information: www.edwards.com