Photo: Medical Device Innovation Consortium
Edwards Lifesciences said Monday, November 2, that its PASCAL tricuspid valve repair system outperformed medical therapy alone on the six-month composite primary endpoint of the CLASP II TR trial. The company presented the findings at the Transcatheter Cardiovascular Therapeutics meeting in San Diego.
The company’s announcement said the repair system reduced tricuspid regurgitation, or backward leakage through the valve, and improved patients’ reported health status, with those effects sustained through one year. The findings described in the release are Edwards’ account of the trial results.
At one year, Edwards said 80% of patients treated with PASCAL had no more than moderate tricuspid regurgitation, compared with 30% in the control group. The company also reported an 18-point improvement in quality of life on the Kansas City Cardiomyopathy Questionnaire among patients treated with the device. The release did not describe that 18-point figure as a difference between the treatment and control groups.
A composite result is not proof of longer survival
The trial’s registered primary endpoint combines outcomes including mortality, right ventricular assist device implantation or heart transplant, further tricuspid valve intervention, heart failure hospitalization and improvement in quality of life. A favorable result on that combined measure does not, by itself, show that the device reduced deaths.
Edwards’ release separately refers to hard-endpoint findings from a different trial, TRIC-I-HF. Those findings should not be treated as a demonstrated survival benefit in CLASP II TR. Monday’s CLASP announcement did not provide a stand-alone mortality benefit estimate.
Edwards described adverse event rates at 30 days as low, but its release did not provide numerical rates. The company said the clinical and quality-of-life evidence adds to the body of research supporting catheter-based treatment for patients with tricuspid valve disease.
The PASCAL system is designed to repair the valve using a catheter-based approach. The randomized CLASP II TR study compares the device plus optimal medical therapy with medical therapy alone in patients with symptomatic severe tricuspid regurgitation.
The new development Monday was the trial report, not a new regulatory clearance. Edwards said the system received U.S. Food and Drug Administration approval for tricuspid valve repair in October 2026 and a European CE Mark in 2020.
Daveen Chopra, Edwards’ corporate vice president for transcatheter mitral and tricuspid therapies, said in the release that the company is developing repair and replacement options intended to support a more personalized treatment path. The trial findings and their limits, rather than claims from other studies, are the basis of Monday’s announcement.
JBizNews Desk | New York
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