FDA Approves PASCAL Repair for Tricuspid Valve

Edwards Lifesciences' PASCAL system outperformed medical therapy alone in the CLASP II TR trial for severe tricuspid regurgitation.

Updated on Nov. 3, 2026 in Heart Disease

Empty hybrid operating suite with a large overhead circular X-ray imaging arm above a surgical table, cool blue-gray palette, clean clinical light. — Edwards Lifesciences said its PASCAL system beat medical therapy alone for severe tricuspid regurgitation in the CLASP II TR trial, and the FDA approved the repair device on October 21. AI Illustration. Upload story photo >

Edwards Lifesciences announced that its PASCAL system outperformed medical therapy alone on the CLASP II TR trial's primary endpoint. The FDA approved PASCAL Precision for tricuspid repair on October 21.

Why it matters

The approval gives certain patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy a catheter-based repair option. Patients at intermediate or greater surgical risk may now have an alternative to open surgery.

The CLASP II TR trial compared PASCAL against medical therapy alone, with 80% of treated patients reaching moderate or lower regurgitation at one year versus 30% of controls. No effect size, p-value, or control-group quality-of-life figure has been released.

The players

Edwards Lifesciences

A medical device company based in Irvine, California, known for developing transcatheter heart valve therapies, including the PASCAL system.

The details

The results were presented at TCT 2026 and announced by Edwards on November 2 at 1:25 p.m. ET. The primary endpoint is hierarchical, combining mortality, durable right ventricular assist device implantation or heart transplant, tricuspid intervention, heart failure hospitalizations, and quality of life improvement.

October 21, 2026: FDA approves PASCAL Precision for tricuspid repair.
November 2, 2026: Edwards announces CLASP II TR results at 1:25 p.m. ET.
Six months: primary endpoint timepoint in the CLASP II TR trial.
One year: follow-up showing 80% of treated patients with moderate or lower TR.

Roadmap

The approval extends catheter-based edge-to-edge repair beyond the mitral valve into the tricuspid valve, a previously harder-to-treat target. It signals growing regulatory support for minimally invasive options for patients who are poor surgical candidates.

Patients with symptomatic severe tricuspid regurgitation who are at intermediate or greater surgical risk may now discuss a catheter-based repair option with their cardiologist. Those whose medical therapy has not controlled symptoms should ask whether they are candidates under the approved indication.

The takeaway

Patients with severe tricuspid regurgitation who continue to have symptoms despite medication should ask their heart care team whether a catheter-based repair is appropriate. Eligibility depends on surgical risk and the approved indication.