Tag: Sapien 3

Edwards’ SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval

IRVINE, Calif., Dec. 28, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients […]

Edwards’ SAPIEN 3 Ultra Transcatheter Heart Valve Receives CE Mark

IRVINE, Calif., Nov. 16, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients. “The SAPIEN 3 Ultra […]

Real-World Evidence Confirms Clinical Trial Outcomes For Patients Treated With Edwards SAPIEN 3 Valve

PARIS, May 22, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced 30-day data demonstrating that treatment with the Edwards SAPIEN 3 valve in more than 450 commercial centers around the U.S. show consistently positive patient outcomes. The […]

Edwards Completes Enrollment In PARTNER 3 Low-Risk CT Sub-Study, Updates Timeline For SAPIEN 3 Ultra System Launch In Europe

IRVINE, Calif., March 21, 2018 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that enrollment is complete in the computed tomography (CT) imaging sub-study within the PARTNER 3 trial of the SAPIEN 3 valve. This randomized sub-study is examining […]