Edwards Lifesciences Corporation

FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease

The FDA approved Edwards Lifesciences' PASCAL Precision system for transcatheter tricuspid valve repair in patients with symptomatic severe tricuspid regurgitation at intermediate or greater surgical risk. The approval makes Edwards the only company offering a portfolio of repair and replacement transcatheter therapies for both the mitral and tricuspid valves in the US. The FDA also approved the PASCAL Ace with Capture Clarity system for degenerative mitral TEER, the first TEER device with fluoroscopic indicators confirming leaflet capture. One-year CLASP IITR pivotal trial data will be presented at TCT.

•11d ago

Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients

Edwards Lifesciences received FDA approval for the AUTUS Size-Adjustable Valve, the first FDA-approved surgical pulmonary valve designed specifically for pediatric anatomy. The valve can be expanded via a minimally invasive transcatheter procedure as a child grows, potentially reducing repeat open-heart surgeries. Approval was based on a pivotal study that met its safety and effectiveness endpoints, with 100% of patients free of device-related complications at 30 days and no valve reinterventions through six months. The approval expands Edwards' congenital heart portfolio alongside SAPIEN 3 and the Alterra Adaptive Prestent; near-term revenue impact is likely modest for a company of Edwards' scale, but it reinforces leadership in structural heart innovation.

•1mo ago

Edwards Lifesciences Comments on TAVR National Coverage Decision

Edwards Lifesciences issued a supportive statement responding to CMS's updated national coverage determination for transcatheter aortic valve replacement, calling the policy an important step toward improving and expanding patient access while preserving the multidisciplinary Heart Team model. The modernized Medicare policy supports a more streamlined patient care journey and gives Heart Teams greater flexibility in evaluating and treating aortic stenosis based on each patient's clinical needs. Edwards cautioned that implementation and adoption of the NCD are expected to take time, reaffirmed its previously communicated 2026 financial guidance, and said 2027 and longer-term guidance will come at its December investor conference.

•1mo ago

Edwards Lifesciences Reports Second Quarter Results

Edwards Lifesciences reported Q2 revenue of $1.74 billion, up 13.6% year-over-year, with TAVR sales growing 11.3% to $1.26 billion and TMTT sales surging 47.3% to $195.9 million. Driven by this stronger-than-expected performance, the company raised its full-year 2026 constant currency sales growth guidance to 10%-11% from 9%-11% and increased its TMTT sales outlook to $760-$780 million. Adjusted EPS guidance was reaffirmed at $2.95-$3.05, supported by a 30% adjusted operating margin, despite GAAP EPS taking a hit from a $188.2M tax valuation allowance related to California legislation.

•3mo ago

Edwards’ Structural Heart Leadership Demonstrated Through Expanding Body of Scientific Evidence at New York Valves

Edwards Lifesciences presented new data at New York Valves 2026, including seven-year benchmark durability data from the PARTNER 3 trial for the SAPIEN 3 platform, underscoring the long-term performance of its flagship technology. Baseline characteristics from the PROGRESS trial revealed that over 95% of moderate aortic stenosis patients were symptomatic and 70% had multiple at-risk features, supporting the strategic rationale for earlier transcatheter intervention. Additional data from a registry of over 4,500 patients confirmed the safety of the PASCAL system, while one-year results from the ENCIRCLE trial demonstrated quality of life improvements with the SAPIEN M3 system.

•4mo ago

Edwards Lifesciences Reports First Quarter Results

Edwards Lifesciences delivered strong Q1 results with sales growing 16.7% to $1.65 billion and adjusted EPS reaching $0.78. Driven by this performance, the company raised its full-year 2026 sales growth guidance to 9% to 11% and adjusted EPS guidance to $2.95 to $3.05. The quarter also featured the completion of a $500 million accelerated share repurchase and the recent FDA approval of the SAPIEN M3 mitral valve.

•6mo ago