Edwards’ Pascal Precision Transcatheter Valve Repair System Approved by FDA to Treat Degenerative MR

September 15, 2022—Edwards Lifesciences Corporation announced that the company’s Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral regurgitation (DMR).

The device was evaluated in the CLASP IID United States pivotal trial composed of patients with symptomatic DMR. The randomized controlled trial compared Pascal Precision with a contemporary TEER system (MitraClip, Abbott Vascular).

Edwards advised that patients treated with the Pascal Precision system in the United States will be enrolled in the TVT Registry for 5 years to build a body of real-world evidence. On August 17, 2022, the company announced that the Pascal Precision system received European CE Mark certification for the treatment of both mitral and tricuspid regurgitation.

According to the company, the Pascal Precision system’s features include independent grasping, atraumatic clasp and closure, and the ability to elongate, which enable safe and effective treatment for patients with DMR. An intuitive catheter and handle allow for maneuverability and stability to enable precise navigation and implant delivery.

Firas Zahr, MD, Associate Professor of Medicine, Division of Cardiovascular Medicine, School of Medicine, Oregon Health & Science University in Portland, Oregon, is a CLASP IID investigator.

“The mitral valve is highly complex and challenging to treat,” commented Dr. Zahr in the company’s press release. “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, United States clinicians now have an additional option for treating patients with severe mitral regurgitation.”

Edwards advised that data from CLASP IID will be presented on September 17 in a late-breaking clinical science session at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.