EW · 10-Q · 2026Q2 · Full report

Product Launch and Transition

Edwards Lifesciences Corp · 2026-08-04 · Importance 44 · Surprise 60

Edwards received FDA approval in January 2026 for the SAPIEN 3 transcatheter pulmonic valve delivery system for pediatric and adult patients with congenital heart disease. In June 2026, the company received CE Mark for SAPIEN M3 RESILIA, expanding access to mitral therapy for patients with mitral annular calcification. Edwards also received FDA approval for TRIFORMIS RESILIA, described as the first surgical tricuspid valve replacement specifically designed for tricuspid valve disease, and FDA 510(k) clearance for ECLIPTIS surgical Left Atrial Appendage technology.