PASCAL Beats Medical Therapy in Tricuspid Repair Trial, 80% Cut to Moderate-or-Less TR
EW sits 22% above its 52-week low of $74.66 on elevated volume (1.9× avg).
Summary
Late-breaking CLASP II TR data at TCT show Edwards' PASCAL tricuspid repair system beat medical therapy alone on the six-month primary endpoint. At one year, 80% of PASCAL patients were at moderate or less tricuspid regurgitation versus 30% of controls, with an 18-point improvement on the Kansas City Cardiomyopathy Questionnaire quality-of-life measure and low 30-day adverse event rates. This is the clinical-evidence backing for a product already approved: the FDA cleared PASCAL for tricuspid repair in October 2026, so the readout supports adoption and reimbursement rather than opening a new market. It lands the same day as the separate PROGRESS TAVR trial win in moderate aortic stenosis, giving Edwards two positive late-breaker datasets in one session. The offsetting overhang is the FDA's October high-risk recall warning on Commander M delivery systems, which still hangs over the transcatheter mitral/tricuspid franchise.
At the time of this announcement, EW was trading at $90.76 on NYSE in the Life Sciences sector, with a market capitalization of approximately $52.3B. The 52-week trading range was $74.66 to $96.29. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.