Edwards Lifesciences Corp NYSE:EW Price, Chart, News & Insight

Edwards Lifesciences Wins FDA Approval for AUTUS Pediatric Pulmonary Valve

Edwards Lifesciences received FDA approval for its AUTUS Size-Adjustable Valve, the first surgical pulmonary valve specifically designed for pediatric patients with congenital heart disease who require pulmonary valve replacement.

A key feature of AUTUS is its ability to expand as a child grows. The valve can be enlarged through a minimally invasive transcatheter procedure, potentially reducing the need for multiple open-heart surgeries over a patient’s lifetime.

The FDA decision was supported by results from a pivotal study that met its primary safety and effectiveness endpoints. All patients were free from device-related complications through 30 days, and no AUTUS valve reinterventions were reported through six months. Among patients completing one-year follow-up, 100% met the study’s valve-performance criteria, including an RVOT mean gradient of 40 mmHg or less, less than moderate pulmonary regurgitation and no valve reinterventions.

Patients will continue to be followed for 10 years. AUTUS had previously received FDA Breakthrough Device designation.

The approval expands Edwards Lifesciences’ congenital heart portfolio, which already includes SAPIEN 3, the Alterra Adaptive Prestent and pediatric atrioseptostomy catheters. For Edwards, AUTUS adds another structural-heart platform and extends its reach into pediatric congenital care, an area with relatively limited treatment options.

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Global Finance News 10-02-26

Edwards Lifesciences reported strong first-quarter 2026 results, with sales rising 16.7% to $1.65 billion and adjusted earnings per share reaching $0.78. Growth was driven by continued demand for its transcatheter aortic valve replacement (TAVR) products, with TAVR sales increasing 14.4% to $1.20 billion.

The company also reported expanding momentum in its transcatheter mitral and tricuspid therapies segment, while completing a $500 million share repurchase program.

Edwards Lifesciences raised its full-year 2026 outlook, now expecting constant currency sales growth of 9% to 11% and higher adjusted EPS, reflecting confidence in continued demand and innovation in structural heart treatments.

Source: Business Wire

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The Investor 04-24-26

Edwards Lifesciences (NYSE: EW) will announce its operating results for the quarter ended March 31, 2026 after the market closes on Thursday April 23

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Global Finance News 04-17-26

Edwards Lifesciences reported positive two-year clinical data for its EVOQUE transcatheter tricuspid valve replacement (TTVR) system, demonstrating sustained patient benefits.

Results from the TRISCEND II Phase III trial showed near elimination of tricuspid regurgitation, improved quality of life, and significantly lower mortality when accounting for patient crossover, with no additional device-related safety risks.

The data, presented at the American College of Cardiology Annual Scientific Session, reinforce the system’s effectiveness in treating patients with limited options for this condition.

The findings support the growing clinical evidence for the EVOQUE system, which is already approved in the U.S. and Europe, highlighting its potential to transform treatment for structural heart disease.
Business Wire

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WS Investor 03-30-26

Edwards Lifesciences Corporation highlighted its continued focus on structural heart innovation and expanded access to care, reaffirming its global health initiative, Every Heartbeat Matters.

As part of the update, the company announced a renewed goal to help 2 million additional patients facing access barriers receive lifesaving structural heart treatment by the end of 2030. Since its launch in 2014, Every Heartbeat Matters and its charitable partners have impacted more than 4 million underserved structural heart patients globally, particularly in low- and middle-income countries.

Management emphasized that the initiative, supported by the Edwards Lifesciences Foundation, aims to reduce financial, systemic and geographic barriers to diagnosis and treatment. The company stated that innovation, clinical expertise and global healthcare partnerships remain central to its strategy to advance science and expand patient access.

Source: Edwards Lifesciences, Business Wire, February 26, 2026.

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The Investor 02-28-26

Edwards Lifesciences (NYSE: EW) announced that its results for the quarter ended December 31, 2025 after the market closes on Tuesday, February 10, and will host a conference call at 5:00 p.m. ET that day to discuss those results.

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WS Investor 02-03-26

Edwards Lifesciences said a U.S. federal court has granted the FTC an injunction blocking its proposed acquisition of JenaValve Technology, and as a result the deal will not proceed. Edwards disagreed with the ruling but stated it will continue advancing its own transcatheter aortic regurgitation programs, including the SOJOURN valve and JOURNEY pivotal trial.

Following the decision, the company raised its full-year 2026 adjusted EPS guidance to $2.90–$3.05 from $2.80–$2.95.

Source: Business Wire.

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The Investor 01-10-26

Edwards Lifesciences announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making it the first transseptal transcatheter therapy approved in the U.S. for treating mitral regurgitation in patients unsuitable for surgery or TEER. Approval was supported by one-year ENCIRCLE trial data showing 95.7% effective MR reduction and significant symptom improvement.

Source: Edwards Lifesciences via Business Wire, December 23, 2025.

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Global Finance News 12-23-25

Edwards Lifesciences Reaffirms Growth Strategy and Provides 2026 Outlook

Edwards Lifesciences reiterated its long-term strategy for sustainable, differentiated growth during its annual investor conference, highlighting its leadership across transcatheter aortic, mitral and tricuspid therapies. CEO Bernard Zovighian said the company is entering 2026 with strong momentum as it advances first-of-its-kind innovations for structural heart conditions, including emerging opportunities in aortic regurgitation and structural heart failure.

The company reaffirmed its 2025 guidance and forecasted 2026 constant-currency sales growth of 8 to 10 percent, with adjusted EPS of 2.80 to 2.95 dollars. Growth is expected across all major segments, including TAVR sales of 4.6 to 4.9 billion dollars at 6 to 8 percent growth, and TMTT sales of 740 to 780 million dollars at up to 45 percent growth. Edwards also anticipates approximately 100 basis points of operating-margin expansion despite planned dilution from the JenaValve acquisition.

Upcoming regulatory and clinical milestones include U.S. guideline updates for TAVR by late 2026, FDA approval of the SAPIEN M3 mitral valve in early 2026, and pivotal trial results expected throughout the year. Edwards highlighted its expanding pipeline, continued global adoption of its SAPIEN platform, and long-term target of roughly 10 percent average annual sales growth driven by both established and emerging structural heart therapies.

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WS Investor 12-05-25

Edwards Lifesciences presents strong mitral and tricuspid valve therapy results at TCT 2025

Edwards Lifesciences (NYSE: EW) unveiled new data at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference demonstrating successful patient outcomes with its SAPIEN M3 and EVOQUE transcatheter systems.

The *ENCIRCLE pivotal trial* for the SAPIEN M3 mitral valve replacement achieved all primary and secondary endpoints at one year, showing a 95.7% rate of mitral regurgitation elimination (≤0/1+) and significant quality-of-life improvements, with findings published in *The Lancet*.

Meanwhile, data from the *EVOQUE tricuspid valve system* registry, covering 1,034 real-world patients, showed lower pacemaker rates (14.9%) and minimal major bleeding (1.3%) versus the pivotal TRISCEND II trial, with 98% of patients experiencing near-complete regurgitation resolution and a median hospital stay of just two days.

Edwards said these results highlight the growing clinical strength of its mitral and tricuspid portfolio, noting that the SAPIEN M3 is approved in Europe and the EVOQUE system is approved in both the U.S. and Europe.

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The Investor 10-27-25

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