HeartStitch wins CE Mark for CoAp Pro mitral valve repair device

HeartStitch said today it won CE Mark approval in the European Union for its CoAp Pro device designed for mitral valve remodeling and repair. The Fountain Valley, Calif.-based company said its CoAp Pro device is designed to allow physicians to remodel mitral valve leaflets to re-establish proper coaptation. “I am especially pleased to see HeartStitch receive this approval, because it provides the ability to use suture to remodel the mitral valves rather than the need to place a prosthetic device in the leaflets. In my opinion it is a significant advancement to the treatment of mitral regurgitation. Personally, I have seen the development of this device from its inception and have participated in the clinical testing, and with my extensive experience with the use of the NobleStitch EL for PFO closure it was a natural evolution for me to use this technology,” Dr. Achille Gaspardone of Rome’s Ospedale Sant’Eugenio said in a prepared statement. “I have been working with the NobleStitch and HeartStitch technologies for more than eight years, and I have seen the development of these devices as they have gone from prototype, to clinical testing, and finally to daily clinical use. The recent advances to perform this procedure through normal venous access were made following the work we did testing in a clinical model. The feasibility of suture-based mitral edge-to-edge ‘Alfieri’ stitching is now a reality,” HeartStitch chief medical of...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory/Compliance HeartStitch Source Type: news