Key Highlights

  • FDA approved PASCAL Precision for transcatheter repair of severe tricuspid regurgitation in selected patients.
  • Edwards says it alone offers repair and replacement therapies for both valves in the U.S.
  • A second approval covers PASCAL Ace with Capture Clarity for mitral procedures.
  • One-year CLASP IITR trial data will be presented at the TCT symposium.

What the FDA Approved

Edwards Lifesciences Corporation (NYSE:EW) announced on Wednesday that the U.S. Food and Drug Administration has approved its PASCAL Precision system for tricuspid valve repair. The device is delivered through a catheter, so patients avoid open heart surgery.

The tricuspid valve sits between two chambers on the right side of the heart. When it fails to close fully, blood leaks backward, a condition called tricuspid regurgitation that can cause tiredness, swelling and breathlessness.

Who Can Receive the Treatment

The approval covers patients with symptomatic severe tricuspid regurgitation who still have symptoms despite optimal medical therapy. They must be judged at intermediate or greater risk for surgery.

A multidisciplinary heart team must also decide that transcatheter edge-to-edge tricuspid valve repair is appropriate. This limits the addressable group to patients for whom open surgery carries meaningful risk.

A Wider Portfolio

Edwards says the approval makes it the only company in the United States with a portfolio of both repair and replacement transcatheter therapies for the mitral and tricuspid valves. A corporate vice president for transcatheter mitral and tricuspid therapies said the addition lets clinicians pick the most suitable option for each patient.

PASCAL has been available in the United States for several years for degenerative mitral regurgitation. Extending it to the tricuspid valve may help Edwards cover more patient anatomies, although the commercial effect depends on adoption by heart teams and on reimbursement, which the company did not address.

A Second Approval: Capture Clarity

The FDA also approved PASCAL Ace with Capture Clarity for degenerative mitral procedures. The company describes it as the first approved device of its type with fluoroscopic indicators that confirm when valve leaflets have been grasped.

A structural heart director at The Christ Hospital Health Network said the indicators offer a simple way to confirm capture and raise confidence in the outcome. As a view tied to the company's release, it is best read as an early impression, not comparative evidence.

Evidence and Open Questions

One-year data from the CLASP IITR pivotal trial of the tricuspid system will be presented in late-breaking sessions at Transcatheter Cardiovascular Therapeutics, the annual symposium of the Cardiovascular Research Foundation. The company did not disclose results in this announcement.

Those data could shape how clinicians view the device against alternatives. Competing therapies, patient selection and procedure volumes remain uncertain.