Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Pascal Precision system for patients with degenerative mitral regurgitation (DMR).
Irvine, California-based Edwards designed its Pascal Precision system for precision transcatheter edge-to-edge repair (TEER) for heart valves.
The system features independent grasping, atraumatic clasp and closure and the ability to elongate. According to a news release, it enables safe and effective treatment for patients with DMR. It includes an intuitive catheter and handle for maneuverability and stability to offer precise navigation and implant delivery.
“Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a large and significantly underserved group in the US,” said Bernard J. Zovighian, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “Edwards’ 60-year history of innovation and leadership within structural heart disease positions our team well to bring the PASCAL Precision system to US clinicians, supporting excellent real-world outcomes for patients.”
Pascal Precision holds CE mark approval for treating both mitral and tricuspid regurgitation. It is the company’s first transcatheter repair or replacement therapy approved for treating DMR in the U.S. Edwards plans to build evidence for the system through a U.S. registry enrolling patients for five years.
Data to come for Pascal
The company will present data from the CLASP IID pivotal trial on Sept. 17 at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. The study directly compares two contemporary TEER therapies.
“The mitral valve is highly complex and challenging to treat,” said Dr. Firas Zahr associate professor of medicine, division of cardiovascular medicine, School of Medicine, Oregon Health & Science University, whose patients participated in the CLASP IID clinical trial. “Through my participation in the CLASP IID pivotal trial, I have performed many cases with the Pascal system. With FDA approval of the Pascal system, U.S. clinicians now have an additional option for treating patients with severe mitral regurgitation.”