Edwards Gains FDA Approval for PASCAL Precision Tricuspid Valve Repair

Edwards Lifesciences has received U.S. Food and Drug Administration (FDA) approval for its PASCAL Precision system to treat tricuspid regurgitation, expanding the device’s use beyond mitral valve repair.

The system is indicated for patients with symptomatic severe tricuspid regurgitation (TR) who remain symptomatic despite optimal medical therapy, face intermediate or greater surgical risk, and are considered appropriate candidates for transcatheter edge-to-edge tricuspid valve repair (T-TEER) by a multidisciplinary heart team.

Tricuspid regurgitation occurs when the heart’s tricuspid valve fails to close properly, allowing blood to flow backward. The condition can impair quality of life and physical function. The PASCAL Precision system is designed to help address the condition through a minimally invasive, catheter-based procedure.

The approval expands the use of a device that received FDA clearance in 2022 for transcatheter edge-to-edge repair of degenerative mitral regurgitation. Edwards said the addition gives it a U.S. portfolio of transcatheter repair and replacement therapies for both the mitral and tricuspid valves.

“With the addition of the PASCAL tricuspid valve repair system to our portfolio of tricuspid transcatheter therapies, Edwards is able to support the treatment of a broader group of tricuspid patients,” said Daveen Chopra, the company’s corporate VP of transcatheter mitral and tricuspid therapies.

The company also announced FDA approval of its PASCAL Ace with Capture Clarity system for degenerative mitral regurgitation procedures. The device incorporates fluoroscopic indicators that help clinicians confirm when the valve leaflets have been grasped, addressing a technically challenging step in transcatheter edge-to-edge repair.

One-year clinical and health-status data from the pivotal CLASP II TR trial evaluating the PASCAL system for tricuspid repair are scheduled for presentation during the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting.