Edwards Lifesciences Corporation (NYSE: EW), a structural heart innovation company, announced on Wednesday that it has received US Food and Drug Administration (FDA) approval for its PASCAL Precision system to repair the tricuspid valve in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy who face intermediate or greater surgical risk.

This approval makes Edwards the only company in the US offering a portfolio of transcatheter repair and replacement therapies for both the mitral and tricuspid valves.

The FDA has also approved the company's PASCAL Ace with Capture Clarity system for degenerative mitral transcatheter edge-to-edge repair (M-TEER). The device is the first FDA-approved TEER system to incorporate fluoroscopic indicators confirming when valve leaflets have been grasped, helping simplify a challenging stage of the procedure.

One-year results from the pivotal CLASP IITR trial evaluating the PASCAL tricuspid system will be presented in late-breaking sessions at the Transcatheter Cardiovascular Therapeutics (TCT) symposium.