Edwards Lifesciences Corp Stock Price, News & Analysis

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.

Edwards Lifesciences (NYSE: EW) reported strong Q2 2025 financial results with sales growing 11.9% to $1.53 billion. The company's TAVR sales increased 8.9% to $1.1 billion, while TMTT sales reached $134.5 million, growing 61.9% year-over-year. Surgical sales grew 7.7% to $267 million.

The company increased its 2025 guidance, now projecting total sales growth of 9-10% to $5.9-6.1 billion, with TAVR sales guidance raised to 6-7%. Adjusted EPS guidance was raised to the high end of $2.40-$2.50. Q2 EPS was $0.57, with adjusted EPS at $0.67.

Notable achievements include SAPIEN platform's approval for asymptomatic patients in U.S. and Europe, CE Mark approval for SAPIEN M3, and strong performance across all product groups. The company maintains a stable competitive position and pricing globally.

[ "Total sales grew 11.9% to $1.53 billion, exceeding expectations", "TMTT sales surged 61.9% year-over-year to $134.5 million", "Increased 2025 sales growth guidance to 9-10% from 8-10%", "SAPIEN platform received approval for asymptomatic patients in US and Europe", "Strong cash position with approximately $3 billion in cash and cash equivalents", "Gross profit margin of 77.5% maintained in line with expectations" ]