Edwards Lifesciences
Irvine, CA 92614
Edwards PASCAL Transcatheter Valve Repair System Receives European Approval for Tricuspid Repair
Irvine, Calif., May 18, 2020 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received CE Mark for the Edwards PASCAL transcatheter valve repair system for the treatment of European patients with tricuspid regurgitation (TR). Although the prevalence...
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Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients
Superior TAVR Valve Available for All Patients Diagnosed with Severe, Symptomatic Aortic Stenosis IRVINE, Calif., Aug. 16, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN...
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Edwards SAPIEN 3 Valve Proves Superior to Surgery in Partner 3 Trial
NEW ORLEANS, March 16, 2019 /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 results of the randomized PARTNER 3 Trial demonstrated superiority for the SAPIEN 3 transcatheter aortic valve over outcomes with surgery. The trial, which compared treatment...
Read More »Edwards PASCAL Transcatheter System Receives CE Mark
Irvine, Calif., Feb. 19, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced the Edwards PASCAL transcatheter valve repair system has received CE Mark for the treatment of patients with mitral regurgitation. Mitral valve disease is complex, varied and...
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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...
Read More »Edwards Granted CE Mark For First Transcatheter Tricuspid Therapy
IRVINE, Calif., April 30, 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 it has received CE Mark for the Edwards Cardioband Tricuspid Valve Reconstruction System for the treatment of tricuspid regurgitation. The Cardioband Tricuspid System is the...
Read More »Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark
IRVINE, Calif., Feb. 15, 2018 - 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 its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards CENTERA valve is repositionable and...
Read More »Edwards' Advanced Hemodynamic Monitoring Platform Receives FDA Clearance
IRVINE, Calif., April 19, 2017 - Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, has received FDA clearance for its HemoSphere advanced monitoring platform. This technology provides clinicians with exceptional clarity on a patient's hemodynamics, or the factors that manage blood flow, to help...
Read More »Edwards Receives FDA Clearance for Advanced Noninvasive Monitoring System
ClearSight system enables clinicians to reduce risk of post-surgical complications IRVINE, CA — Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the ClearSight system. The ClearSight system is a noninvasive monitor that provides...
Read More »Edwards Receives Reimbursement Approval for Sapien XT Valve in Japan
IRVINE, CA- – Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare's (MHLW) expert review panel to provide reimbursement for the Edwards SAPIEN XT transcatheter...
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Edwards PASCAL Transcatheter Valve Repair System Receives European Approval for Tricuspid Repair
Irvine, Calif., May 18, 2020 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received CE Mark for the Edwards PASCAL transcatheter valve repair system for the treatment of European patients with tricuspid regurgitation (TR). Although the prevalence...
Read More »Edwards SAPIEN 3 TAVI Receives Expanded Approval in Europe
Superior TAVI Valve Indicated for All Patients Diagnosed with Aortic Stenosis Irvine, Calif., Nov. 6, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received CE Mark to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the...
Read More »Edwards SAPIEN 3 TAVR Demonstrates Significant Health Status Improvements for Low-Risk Patients
SAN FRANCISCO, Sept. 29, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced new data demonstrating early and sustained health status advantages for severe aortic stenosis (AS) patients at low surgical risk treated with the Edwards SAPIEN 3 valve. Study...
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Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients
Superior TAVR Valve Available for All Patients Diagnosed with Severe, Symptomatic Aortic Stenosis IRVINE, Calif., Aug. 16, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN...
Read More »Edwards Comments on Updated TAVR National Coverage Determination
IRVINE, Calif., June 21, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today commented on the final updated U.S. Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) pertaining to transcatheter aortic valve replacement (TAVR) programs:...
Read More »Edwards Lifesciences Recommends Stockholders Reject Mini-Tender Offer by TRC Capital Corporation
IRVINE, Calif., June 3, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received notice of an unsolicited mini-tender offer by TRC Capital Corporation to purchase up to 1,000,000 shares, or approximately 0.48 percent of the company's...
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Edwards SAPIEN 3 Valve Proves Superior to Surgery in Partner 3 Trial
NEW ORLEANS, March 16, 2019 /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 results of the randomized PARTNER 3 Trial demonstrated superiority for the SAPIEN 3 transcatheter aortic valve over outcomes with surgery. The trial, which compared treatment...
Read More »Edwards Lifesciences Announces Strategic Investments
IRVINE, Calif., March 11, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced two strategic transactions involving companies with structural heart disease technologies. Edwards has invested $35 million in an exclusive right to acquire Corvia Medical, Inc., the...
Read More »Edwards PASCAL Transcatheter System Receives CE Mark
Irvine, Calif., Feb. 19, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced the Edwards PASCAL transcatheter valve repair system has received CE Mark for the treatment of patients with mitral regurgitation. Mitral valve disease is complex, varied and...
Read More »Edwards Lifesciences Enters Into Agreement to Acquire CASMED
Irvine, Calif. and Branford, Conn., Feb. 12, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has entered into a definitive merger agreement to acquire CAS Medical Systems, Inc. (NASDAQ: CASM) (CASMED), a medical technology company dedicated to...
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