SAN DIEGO–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced results from the PROGRESS Trial, marking a turning point in the management of moderate aortic stenosis (AS). The trial demonstrated that transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance in the primary composite endpoint of death or heart failure events at two years in moderate AS patients with at-risk features. The late-breaking results were presented at Transcatheter Cardiovascular Th
Tag: Edwards
FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences Corporation (NYSE: EW) today announced that the U.S. Food and Drug Administration (FDA) has approved its PASCAL Precision system for tricuspid valve repair. The system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical […]
Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients
IRVINE, Calif.–(BUSINESS WIRE)– Edwards Lifesciences (NYSE: EW) today announced that the U.S. Food and Drug Administration (FDA) has approved the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed specifically for pediatric patients with congenital heart disease who require pulmonary valve replacement. For many pediatric patients, pulmonary valve replacement is not […]
FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system […]
Edwards Lifesciences Reaffirms Strategy for Sustainable, Differentiated Growth at Annual Investor Conference
Innovation with Purpose, Powered by Science, Centered on Patients: Edwards’ Commitment to Drive Value for the Healthcare Ecosystem IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) will outline its patient-focused strategy and share financial guidance during its annual investor conference. Entering 2026 with momentum for sustainable differentiated growth, Edwards is uniquely positioned with […]
Prompt Intervention for Severe Aortic Stenosis Patients Demonstrates Lower Healthcare Costs, Improved Clinical Outcomes
PARIS–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced new economic and clinical evidence on severe aortic stenosis (AS) presented as a late-breaking clinical trial at EuroPCR 2025, further contributing to the extensive body of research on this disease. The results of a new real-world study of more than 24,000 patients demonstrated […]
Edwards’ SAPIEN 3 Ultra RESILIA Valve Demonstrates Continued Excellent Outcomes for Patients in Real World Data
November 25, 2024 03:30 AM Eastern Standard Time LONDON–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve. The data were presented at PCR London Valves 2024 and simultaneously published in the Journal of the American College of Cardiology (JACC): […]
Groundbreaking Data Demonstrate Superiority of EARLY TAVR in Asymptomatic Severe Aortic Stenosis Patients
WASHINGTON–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced results from the EARLY TAVR Trial, the first randomized, controlled trial designed to study the best strategy for treating asymptomatic severe aortic stenosis (AS) and the benefits of early intervention with transcatheter aortic valve replacement (TAVR). The trial results demonstrated that asymptomatic severe […]
Edwards Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix
July 24, 2024 04:15 PM Eastern Daylight Time IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology, […]
Edwards Launches the SAPIEN 3 Ultra RESILIA Valve in Europe With Technology to Enhance Durability
NYON, Switzerland–(BUSINESS WIRE)–Edwards Lifesciences today announced the European launch of the SAPIEN 3 Ultra RESILIA valve, the only transcatheter aortic heart valve to incorporate the company’s breakthrough RESILIA tissue technology, designed to extend the valve’s durability.* Edwards’ SAPIEN 3 Ultra RESILIA valve recently received CE Mark† for use in patients with […]


