FDA Approves Pascal Precision System for Mitral Regurgitation

The US Food and Drug Administration (FDA) has approved the PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) in patients with degenerative mitral regurgitation (MR).

The system's independent grasping, atraumatic clasp and closure, along with its ability to elongate, "enables safe and effective treatment" for patients with degenerative MR, Edwards Lifesciences said in a press release today.

Its intuitive catheter and handle are designed for maneuverability and stability, enabling precise navigation and implant delivery, the company says.

"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," Firas Zahr, MD, Oregon Health and Science University, Portland, said in the release.

Data from the CLASP IID pivotal trial, the first randomized controlled trial to directly compare two contemporary TEER therapies, will be presented in a late-breaking session on Saturday, September 17, at the annual Transcatheter Cardiovascular Therapeutics 2022 scientific symposium.

The PASCAL Precision system already has CE Mark certification in Europe for the treatment of mitral and tricuspid regurgitation.

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Cite this: FDA Approves Pascal Precision System for Mitral Regurgitation - Medscape - Sep 15, 2022.