EW · 10-Q · 2026Q2 · Full report
Regulatory Approval Milestones
Edwards Lifesciences Corp · 2026-08-04 · Importance 38 · Surprise 60 · In source text
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 approval for SAPIEN M3 RESILIA, expanding access to therapy for patients with mitral annular calcification. Edwards also received FDA approval in May 2026 for TRIFORMIS RESILIA, described as the first surgical tricuspid valve replacement designed specifically for tricuspid valve disease. In June 2026, FDA 510(k) clearance was granted for ECLIPTIS, the company’s surgical Left Atrial Appendage technology.
Key facts
- In January 2026, Edwards received FDA approval for the SAPIEN 3 transcatheter pulmonic valve delivery system. source
- In June 2026, Edwards received CE Mark for the SAPIEN M3 RESILIA. source
- In May 2026, Edwards received FDA approval for TRIFORMIS RESILIA, the first-ever surgical tricuspid valve replacement designed specifically for patients with tricuspid valve disease. source
- In June 2026, Edwards received FDA 510(k) clearance for ECLIPTIS, its surgical Left Atrial Appendage technology. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | In January 2026, Edwards received FDA approval for the SAPIEN 3 transcatheter pulmonic valve delivery system. |
| revenue | positive | probable | — | In June 2026, Edwards received CE Mark for the SAPIEN M3 RESILIA. |
| revenue | positive | probable | — | In May 2026, Edwards received FDA approval for TRIFORMIS RESILIA, the first-ever surgical tricuspid valve replacement designed… |
| revenue | positive | probable | — | In June 2026, Edwards received FDA 510(k) clearance for ECLIPTIS, its surgical Left Atrial Appendage technology. |