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 officer Dr. Michael Mullen said in a prepared release.
The system uses sutures in place of a full prosthetic device to repair the mitral valve leaflets, which HeartStitch claims is a less invasive percutaneous procedure than other solutions.
“With each new device we are continuing to grow HeartStitch to become the global leader in cardiovascular solutions. While the CoAp has an advanced design, it still retains the intuitive nature and ease-of-use which is the cornerstone of our cardiovascular device line. In creating new suture-based solutions to treat cardiac disease we continue to provide physicians products that become their first choice to deliver the best outcomes for their patients,” HeartStitch prez Dru Dobbs said in prepared remarks.
“This CE Mark again shows that we have the ability to continue to grow our technology platform for many indications. The NobleStitch EL has played a significant part in our company’s ability to have physicians believe in percutaneous suture-based solutions for the treatment of structural heart disease. Doctors worldwide have been asking me for several years to use the NobleStitch EL for these indications,” HeartStitch founder Anthony Nobles said in a press release.
Last week, HeartStitch announced that it won CE Mark approval in the European Union for its suture-based Trans-Apical Access and Closure device.