Edwards Lifesciences Corporation reports developments in structural heart medical technology, including surgical tissue valves, transcatheter aortic valve replacement, and transcatheter mitral and tricuspid therapies. Company news commonly covers the SAPIEN TAVR platform, PASCAL transcatheter edge-to-edge repair technology, the EVOQUE transcatheter tricuspid valve replacement system, and RESILIA tissue used in surgical and transcatheter valve innovations.
Recurring updates include quarterly results, clinical-trial data presented at cardiovascular meetings, reimbursement and guideline developments affecting valve procedures, product pipeline commentary, healthcare conference appearances, access initiatives for structural heart treatment, and finance leadership or governance announcements.
Edwards Lifesciences (EW) raised its full-year sales growth outlook to approximately 11.5% after reporting growth across its medical-device businesses. Third-quarter sales rose 10.5% to $1.72 billion; the outlook is on a constant currency basis. Adjusted earnings guidance increased to $2.97–$3.05 per share.
Vertex (VRTX) raised 2026 revenue guidance to $13.15–$13.25 billion, while Humana (HUM) raised adjusted earnings guidance to at least $9.50 per share despite an expected year-over-year decline. McKesson (MCK) raised fiscal 2027 adjusted earnings guidance to $45.60–$46.40 per diluted share. Johnson & Johnson (JNJ) received accelerated FDA approval for RYBREVANT FASPRO in previously treated head and neck cancer, excluding HPV-associated oropharyngeal cancer. Continued approval may depend on confirmation of clinical benefit in the ongoing Phase 3 OrigAMI-5 trial.
Edwards Lifesciences (NYSE: EW) reported third-quarter sales of $1.72 billion from continuing operations and raised its full-year outlook. Sales grew 10.5% year over year, or 11.2% excluding currency effects and newly acquired products. Diluted earnings per share from continuing operations were $0.53; adjusted EPS rose 19% to $0.80.
Aortic valve replacement sales grew 8.0% to $1.24 billion. Adjusted mitral and tricuspid therapy sales rose 44.0% to $207 million, excluding Implantable Heart Failure Management revenue. Surgical sales increased 2.5% to $264 million. Edwards now expects approximately 11.5% full-year sales growth and adjusted EPS of $2.97–$3.05. Recent approvals covered PASCAL mitral and tricuspid therapies, EVOQUE transjugular access and the AUTUS pediatric valve. Cash was approximately $3.1 billion and debt approximately $600 million at September 30, 2026.
Edwards Lifesciences (NYSE: EW) announced that its PASCAL tricuspid repair system demonstrated superiority over medical therapy alone on CLASP II TR’s six-month primary endpoint.
At one year, 80% of PASCAL-treated patients had moderate or less tricuspid regurgitation, or backward blood flow through the tricuspid valve, versus 30% in the control group. Treated patients also showed an 18-point improvement in quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Reductions in regurgitation and improvements in health status were sustained through one year. Adverse event rates were low at 30 days.
The results were presented at Transcatheter Cardiovascular Therapeutics. PASCAL received FDA approval for tricuspid valve repair in October 2026 and CE Mark in 2020.
Edwards Lifesciences (NYSE: EW) reported that its PROGRESS trial showed transcatheter aortic valve replacement outperformed surveillance in at-risk moderate aortic stenosis patients.
The randomized trial enrolled 744 patients and tested the Edwards SAPIEN 3 platform. At two years, the combined endpoint of death or heart failure events occurred in 16.7% versus 23.9% with surveillance, a reported 33% relative reduction. Heart failure hospitalizations occurred in 7.4% versus 14.9%; all-cause mortality was similar. At 30 days, valve replacement had no deaths or disabling strokes, and patients had a 15.5-point improvement in a questionnaire measuring quality of life.
Among surveillance patients, 27% underwent delayed valve replacement within one year and 57% within two years. Results were published in The New England Journal of Medicine. SAPIEN 3 use for moderate aortic stenosis remains investigational.
Edwards Lifesciences (NYSE: EW) has received FDA approval for its PASCAL Precision system to repair the tricuspid heart valve. The indication covers improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy. Patients must be at intermediate or greater surgical risk and deemed appropriate for transcatheter edge-to-edge repair by a multidisciplinary heart team.
The FDA also approved PASCAL Ace with Capture Clarity for degenerative mitral transcatheter edge-to-edge repair. Its fluoroscopic indicators confirm when valve leaflets have been grasped. One-year data from the CLASP IITR pivotal trial studying the PASCAL tricuspid system will be presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics.
Edwards Lifesciences (EW) plans to release quarterly operating results and host an earnings conference call on November 4, 2026.
The results cover the quarter ended September 30, 2026 and are scheduled for release after the market closes. The call begins at 5:00 p.m. ET that day and will be available live and archived on the company's investor relations website.
Edwards Lifesciences (NYSE: EW) will host an investor event on Nov. 2 in conjunction with the TCT scientific symposium in San Diego. The event runs from 5:00 to 6:00 PM Pacific Time and includes live questions and answers with physicians and Edwards management. A live webcast will be available on the investor relations website, with an archive accessible later that day.
Edwards Lifesciences (NYSE: EW) received FDA approval for the AUTUS Size-Adjustable Valve for pediatric patients with congenital heart disease requiring pulmonary valve replacement.
The valve can expand as a child grows through a minimally invasive catheter procedure, potentially reducing repeat open-heart surgeries. Approval was based on the pivotal study, which met its primary safety and effectiveness endpoints: 100% of patients were free from device-related complications through 30 days, with no AUTUS valve reinterventions through six months. Among patients completing one-year follow-up, 100% had a mean pressure gradient across the right ventricular outflow tract of 40 mmHg or less, less than moderate backward blood flow through the pulmonary valve, and no valve reinterventions. Patients will be followed for 10 years. The approval expands Edwards’ congenital treatment options.
Edwards Lifesciences (EW) commented on the updated national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) issued by the Centers for Medicare & Medicaid Services. The company said the policy is an important step toward improving and expanding patient access to TAVR and reinforces the role of the multidisciplinary Heart Team.
Edwards highlighted that the modernized NCD supports a more streamlined patient care journey and gives Heart Teams greater flexibility to tailor evaluation and treatment to each patient’s clinical needs. The company stated that the updated policy creates opportunities for patients and TAVR programs and reaffirmed confidence in its previously communicated 2026 financial guidance. Edwards plans to provide 2027 and longer-term guidance at its investor conference in December.
Edwards Lifesciences (EW) will participate in the Deutsche Bank Healthcare Summit on Wednesday, September 16, 2026. Chief executive officer Bernard Zovighian is scheduled to present at 10:00 a.m. ET, with chief financial officer Doretta Mistras also taking part in the conference.
A live webcast and same-day archived replay will be available on the company’s investor relations website.