FDA Approves Edwards Lifesciences' PASCAL Precision Transcatheter Valve Repair System For Most Frequent Cardiovascular Disorder

The FDA has approved Edwards Lifesciences Corp's EW PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) for degenerative mitral regurgitation (DMR).
TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device, similar to a treatment developed in cardiac surgery called the Alfieri stitch.
The PASCAL Precision system, with its grasping, atraumatic clasp and closure, and ability to elongate, enables safe and effective treatment for patients with DMR.
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Engineered with an intuitive catheter and handle, the system is designed for maneuverability and stability, enabling precise navigation and implant delivery.
Data from the CLASP IID pivotal trial comparing two contemporary TEER therapies will be presented at the Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
The commercial opportunity related to this approval is factored into 2022 financial expectations.
Price Action: EW shares are up 2.39% at $96.37 on the last check Thursday.