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Edwards Lifesciences Corporation (NYSE: EW) generates frequent news as a structural heart medical device company focused on therapies for complex valve disease and structural heart failure. Company announcements highlight developments across transcatheter aortic valve replacement (TAVR), transcatheter mitral and tricuspid therapies (TMTT), and surgical heart valve technologies, as well as clinical data, regulatory milestones and corporate updates.
News coverage often features clinical trial readouts and registry data for key Edwards platforms, including the SAPIEN TAVR valves, the SAPIEN M3 mitral valve replacement system, and the EVOQUE tricuspid valve replacement system. Releases describe long‑term outcomes from the PARTNER trial series, pivotal ENCIRCLE TMVR results, and real‑world EVOQUE registry findings, with a focus on safety, durability, regurgitation reduction and quality‑of‑life improvements for patients with limited treatment options.
Investors and clinicians can also follow regulatory and guideline‑related updates, such as U.S. Food and Drug Administration approvals for new transcatheter therapies, European CE Mark decisions, and evolving professional society guidelines for aortic, mitral and tricuspid disease management. Corporate news includes earnings releases, financial guidance, share repurchase announcements, participation in major healthcare conferences and leadership transitions disclosed through press releases and 8‑K filings.
In addition, Edwards Lifesciences reports on collaborations and initiatives in the broader cardiovascular ecosystem, such as its founding sponsorship of the American Heart Association’s Heart Valve Initiative. For readers tracking EW news, this mix of clinical, regulatory, financial and partnership updates provides insight into how the company is advancing structural heart therapies and executing its strategy over time.
Edwards Lifesciences (NYSE: EW) announced a founding sponsorship of the American Heart Association’s Heart Valve Initiative on November 9, 2025 to improve care for the more than 28 million people with heart valve disease worldwide. The initiative aims to reduce U.S. deaths linked to valve disease (over 60,000 annually) by improving diagnosis, treatment access, clinician training, data collection, hospital certification, public reporting and patient education.
Planned actions span five years and build on the existing Target: Aortic Stenosis program to accelerate earlier recognition and faster treatment.
Edwards Lifesciences (NYSE: EW) announced that Chief Financial Officer Scott Ullem will transition from his CFO role by midyear 2026. The company is initiating a selection process to appoint a new CFO, and Ullem will remain in an advisory role after a successor is named. Management said the planned timing is intended to enable continuity and a smooth transfer of responsibilities during the transition.
Contact information for media and investors was provided. The release includes standard forward-looking statement disclosures and directs readers to the company website for filings and safety information.
Summary not available.
Edwards Lifesciences (NYSE: EW) presented new mitral and tricuspid clinical data at TCT 2025 showing strong patient outcomes.
Key highlights: the ENCIRCLE single-arm pivotal trial (main cohort n=299) met all one-year primary and secondary endpoints with 95.7% MR ≤ 0/1+ and low death and heart-failure hospitalization rates using the SAPIEN M3 system. The EVOQUE TTVR STS/ACC TVT Registry (n=1,034) reported 98% TR ≤ 0/1+, a 14.9% pacemaker rate, 1.3% major bleeding at 30 days, and median hospital stay of 2 days. SAPIEN M3 is approved in Europe (April 2025) and not yet approved in the US; EVOQUE is approved in both US and Europe.
Edwards Lifesciences (NYSE: EW) presented seven-year PARTNER 3 data at TCT 2025 and published results in The New England Journal of Medicine showing sustained benefits and durable valve performance for SAPIEN 3 TAVR versus surgical aortic valve replacement (SAVR).
At seven years, bioprosthetic valve failure was 6.9% for SAPIEN 3 versus 7.3% for SAVR, and reintervention rates were 6.0% vs 6.7%. All-cause and cardiovascular mortality were similar and health-status gains were sustained. Edwards also highlighted >10-year PARTNER program data, including 10-year follow-up of >3,000 PARTNER 2 patients, and noted the SAPIEN platform has treated >1 million patients worldwide.
Edwards Lifesciences (NYSE: EW) will report operating results for the quarter ended September 30, 2025 after market close on Thursday, October 30, 2025. The company will host an earnings conference call on October 30, 2025 at 5:00 p.m. ET to discuss results.
Dial-in numbers to participate are (877) 704-2848 or (201) 389-0893. The call will be available live and archived on the company Investor Relations website at ir.edwards.com. Media contact: Amy Meshulam, 949-250-4009. Investor contact: Mark Wilterding, 949-250-6826.
Edwards Lifesciences (NYSE: EW) welcomes updated ESC/EACTS guidelines for valvular heart disease, marking significant advancements in structural heart disease treatment. The new guidelines introduce a simplified care pathway for severe aortic stenosis (AS) patients and lower the TAVR age threshold to 70 years.
Key highlights include the approval for asymptomatic severe AS treatment, where Edwards is currently the only company with approved TAVR indication in US and Europe. The company's SAPIEN platform has treated over 1 million patients to date. Additionally, new data from the TRISCEND II study showed that the EVOQUE TTVR system significantly reduced heart failure hospitalizations at 18 months and demonstrated superior clinical benefits versus medical therapy at 1-year.
[ "Only company with approved TAVR indication for asymptomatic severe AS in US and Europe", "SAPIEN platform has treated over 1 million patients", "EVOQUE TTVR system showed significant reduction in heart failure hospitalizations", "New guidelines expand patient access by lowering TAVR age threshold to 70" ]Pulnovo Medical has appointed Dr. Francis Duhay, MD, MBA, FACS as Global Chief Medical Officer. Dr. Duhay, a board-certified General and Cardiothoracic Surgeon, brings over 25 years of experience in clinical medicine, medical device innovation, and executive leadership.
As former Chief Medical Officer at Edwards Lifesciences (NYSE: EW), Dr. Duhay was instrumental in developing the TAVR program, which generates over $4.0 billion in annual revenue across 80+ countries. His experience includes leading 88 clinical studies and working with key regulatory bodies like FDA and CMS.
This appointment strengthens Pulnovo's global medical leadership as it advances its Pulmonary Artery Denervation (PADN) program and expands internationally.
Edwards Lifesciences (NYSE: EW), a global structural heart innovation leader, has announced a $500 million accelerated share repurchase (ASR) agreement. The company will receive an initial delivery of approximately 5 million shares, with the final number to be determined based on the volume-weighted average share price during the agreement term.
This transaction brings Edwards' total share repurchases in 2025 to over $800 million. The company will fund the ASR using existing cash reserves. Following this repurchase, Edwards retains approximately $600 million in its Board-authorized share repurchase program.
Edwards Lifesciences (NYSE: EW) faces opposition from the U.S. Federal Trade Commission (FTC) regarding its proposed acquisition of JenaValve Technology. The FTC has moved to block the transaction, which Edwards believes would enhance treatment options for patients with aortic regurgitation (AR).
Despite the regulatory challenge, Edwards plans to pursue approval, expecting a final determination by Q1 2026. The company has revised its 2025 guidance, maintaining revenue projections while increasing adjusted EPS guidance to $2.45-$2.55 from $2.40-$2.50. Q3 adjusted EPS guidance remains largely unchanged.