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

• The FDA has approved Edwards Lifesciences Corp's (NYSE: 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.

• Related: Edwards Lifesciences Shares Slide As Q2 Results Miss Expectations, Lowers FY22 Sales Outlook.

• 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.

See more from Benzinga

• Alnylam/Regeneron-Backed NASH Candidate Shows Encouraging Safety Profile In Healthy Volunteers

• Tenax Therapeutics Stock Jumps On Strategic Alternative Review

• Donald Trump Won't Be Welcome, Joe Biden Asked To Ride The Bus To Queen Elizabeth II's Funeral

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.