WASHINGTON (dpa-AFX) - Edwards Lifesciences (EW) reported positive results from its CLASP II TR trial, showing that the PASCAL transcatheter valve repair system outperformed medical therapy alone in patients with tricuspid regurgitation, a heart valve condition that causes blood to flow backward through the heart.
Tricuspid regurgitation (TR) can lead to symptoms such as fatigue, shortness of breath and fluid buildup, often reducing quality of life and increasing the risk of heart failure.
The CLASP II TR study found that patients treated with the PASCAL system experienced significant improvements in both valve function and overall health status compared with those receiving medical therapy alone.
After one year, 80% of patients treated with the PASCAL system achieved moderate or less severe tricuspid regurgitation, compared with 30% of patients in the control group.
Patients treated with the device also reported a clinically meaningful 18-point improvement in quality-of-life scores, as measured by the Kansas City Cardiomyopathy Questionnaire.
The study demonstrated a favorable safety profile with low rates of adverse events reported with tricuspid valve disease. Edward noted that the PASCAL system received FDA approval for tricuspid valve repair in October 2026 and has already been used to treat thousands of patients worldwide.
The late-breaking results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 meeting and further support the use of the PASCAL system as a treatment option for patients with symptomatic tricuspid regurgitation.
The company has plans to announce its Q3 2026 results on November 4, 2026, after market close.
EW has traded between $74.66 and $96.29 over the past year. The stock closed Monday's trading at $93.26, up 1.36%.
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