Device Repairs Leaking Tricuspid Valve in Trial

Patients with severe tricuspid leakage at intermediate surgical risk gained a new FDA-approved repair option.

Updated on Nov. 3, 2026 in Heart Disease

Isometric editorial illustration of a cream valve form with two parted leaflets set inside an oxblood heart-chamber cutaway, with a teal flow line passing through it. — The FDA approved Edwards Lifesciences' PASCAL Precision device on October 21 to repair leaking tricuspid valves in certain symptomatic patients at intermediate or greater surgical risk. AI Illustration. Upload story photo >

Edwards Lifesciences reported that its PASCAL transcatheter system outperformed medical therapy alone on the CLASP II TR trial's hierarchical primary endpoint, and the FDA approved PASCAL Precision for tricuspid repair on October 21. The approval covers certain patients with symptomatic severe tricuspid regurgitation who remain symptomatic despite optimal medical therapy and are at intermediate or greater surgical risk.

Why it matters

Tricuspid regurgitation, a leak in the valve between the right-side chambers of the heart, has long been treated mainly with medication, so a device option that the trial showed improved valve function could change treatment conversations for eligible patients. The results were released alongside a new FDA approval, placing a clinical trial result and regulatory decision in the same window for U.S. clinicians and patients.

The findings come from the randomized CLASP II TR trial, which compared the PASCAL system against medical therapy alone. At one year, 80% of PASCAL-treated patients had moderate or lower tricuspid regurgitation compared with 30% of control patients, but the release did not include an effect size, p-value, or separate results for the primary endpoint's components.

The players

Edwards Lifesciences

A medical device company known for transcatheter heart valve therapies, including its PASCAL system for valve repair.

U.S. Food and Drug Administration

The federal agency responsible for reviewing and approving medical devices and drugs for use in the United States.

The details

Tricuspid regurgitation is leakage through the tricuspid valve, which allows blood to flow backward and can strain the heart over time. The CLASP II TR trial's 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 into one composite measure. Because the company released the composite outcome without breaking out each component, the contribution of individual events to the result cannot yet be assessed.

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

Health Landscape

Tricuspid valve disease has historically been managed with medication and monitoring rather than catheter-based repair, which is why a device option tested against medical therapy alone is notable. The CLASP II TR results add trial-level evidence to a field where catheter repair options are expanding into conditions once treated primarily with drugs.

If you have been diagnosed with severe tricuspid regurgitation and are still symptomatic on medication, this development is worth raising with your cardiologist as a treatment option to discuss. Eligibility depends on surgical risk and symptom status, so the conversation should center on whether the approved indication matches your situation.

The takeaway

Catheter-based tricuspid repair now has an FDA-approved option for certain patients with symptomatic severe disease who are at intermediate or greater surgical risk. If this describes you, bring the approval's criteria to your cardiologist and ask whether you qualify.