EW · 10-Q · 2026Q3 · Full report
Product Launch and Transition
Edwards Lifesciences Corp · 2026-11-04 · Importance 38 · Surprise 60 · In source text
Edwards received FDA approval in January 2026 for the SAPIEN 3 transcatheter pulmonic valve delivery system, intended for pediatric and adult patients with congenital heart disease. In TMTT, the company received CE Mark for SAPIEN M3 RESILIA, CE Mark and FDA approval for trans-jugular access with EVOQUE, and FDA approval for PASCAL Ace with Capture Clarity, which provides real-time indication of leaflet capture. In October, FDA approvals included the PASCAL Precision System for tricuspid valve repair and the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed for pediatric patients; earlier surgical milestones included FDA approval for TRIFORMIS RESILIA and 510(k) clearance for ECLIPTIS.
Key facts
- In January 2026, Edwards Lifesciences received FDA approval for the SAPIEN 3 transcatheter pulmonic valve delivery system for pediatric and adult patients with congenital heart disease. source
- In June 2026, Edwards Lifesciences received CE Mark for SAPIEN M3 RESILIA, increasing access to therapy for patients with mitral annular calcification. source
- Edwards Lifesciences received CE Mark in August 2026 and FDA approval in September 2026 for EVOQUE trans-jugular access, enabling treatment of patients with complex femoral access. source
- In September 2026, Edwards Lifesciences received FDA approval for the PASCAL Ace with Capture Clarity System, the first TEER device to provide real-time indication of leaflet capture. source
- In October 2026, Edwards Lifesciences received FDA approval for the PASCAL Precision System for tricuspid valve repair in patients with symptomatic severe tricuspid regurgitation. source
- In May 2026, Edwards Lifesciences received FDA approval for TRIFORMIS RESILIA, its first surgical tricuspid valve replacement designed specifically for patients with tricuspid valve disease. source
- In June 2026, Edwards Lifesciences received FDA 510(k) clearance for ECLIPTIS, its surgical Left Atrial Appendage technology. source
- In October 2026, Edwards Lifesciences received FDA approval for AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed for pediatric patients with congenital heart disease requiring pulmonary valve replacement. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | In January 2026, Edwards Lifesciences received FDA approval for the SAPIEN 3 transcatheter pulmonic valve delivery system for pediatric… |
| revenue | positive | contingent | — | In June 2026, Edwards Lifesciences received CE Mark for SAPIEN M3 RESILIA, increasing access to therapy for patients with mitral annular… |
| revenue | positive | contingent | — | Edwards Lifesciences received CE Mark in August 2026 and FDA approval in September 2026 for EVOQUE trans-jugular access, enabling… |
| revenue | positive | contingent | — | In September 2026, Edwards Lifesciences received FDA approval for the PASCAL Ace with Capture Clarity System, the first TEER device to… |
| revenue | positive | contingent | — | In October 2026, Edwards Lifesciences received FDA approval for the PASCAL Precision System for tricuspid valve repair in patients with… |
| revenue | positive | contingent | — | In May 2026, Edwards Lifesciences received FDA approval for TRIFORMIS RESILIA, its first surgical tricuspid valve replacement designed… |
| revenue | positive | contingent | — | In June 2026, Edwards Lifesciences received FDA 510(k) clearance for ECLIPTIS, its surgical Left Atrial Appendage technology. |
| revenue | positive | contingent | — | In October 2026, Edwards Lifesciences received FDA approval for AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed for… |