FDA OKs Edwards' Transcatheter Valve Repair System

It features an independent grasping, atraumatic clasp and closure, and the ability to elongate.

Edwards Lifesciences

Edwards Lifesciences today announced 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 PASCAL Precision system, with its independent grasping, atraumatic clasp and closure, and ability to elongate, enables treatment for patients with DMR. Engineered with an intuitive catheter and handle, the system is designed for maneuverability and stability, enabling precise navigation and implant delivery.

"The mitral valve is highly complex and challenging to treat," said Firas Zahr, M.D., 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, US clinicians now have an additional option for treating patients with severe mitral regurgitation."

Data from the CLASP IID pivotal trial, the first randomized controlled trial to directly compare two contemporary TEER therapies, will be presented as a late-breaking clinical science session on Sept. 17 at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

The PASCAL Precision system has CE Mark certification for the treatment of both mitral and tricuspid regurgitation. As part of Edwards' continued commitment to building a body of real-world evidence, patients receiving treatment with the PASCAL Precision system in the US will be enrolled in the TVT registry for five years.

The PASCAL Precision system is one of multiple transcatheter repair or replacement therapies in development by Edwards that are designed to address mitral and tricuspid valve disease, and the company's first such therapy approved for DMR in the US. Edwards is committed to transforming the treatment of mitral and tricuspid patients, supported by a robust body of clinical evidence. The commercial opportunity related to this approval is factored into 2022 financial expectations.

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