Edwards Lifesciences

Fluid & Gas Flow Equipment

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...

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Controls & Controllers

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...

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Communication Systems & Equipment

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...

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Fluid & Gas Flow Equipment

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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Fluid & Gas Flow Equipment

Edwards Lifesciences Receives Approval for SAPIEN XT in Japan

IRVINE, CA- – Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards SAPIEN XT valve, making it the country's first commercially available transcatheter aortic heart valve. The company expects to obtain reimbursement approval...

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Health, Medical, & Dental Supplies and Equipment

FDA Approves Expanded Indication for Edwards Lifesciences' Transcatheter Valve

IRVINE, CA - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that it has received approval from the United States Food and Drug Administration (FDA) to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and...

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Fluid & Gas Flow Equipment

EDWARDS INTUITY Valve System Receives CE Mark

IRVINE, CA - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark in Europe for its EDWARDS INTUITY Valve System for use in patients undergoing surgical aortic valve replacement (AVR). The system, which consists of a bovine pericardial heart valve and novel delivery system,...

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Health, Medical, & Dental Supplies and Equipment

Clinical Monitoring Platform aids accurate diagnoses.

With touchscreen monitor and 510(k) clearance from FDA, EV1000 clinical monitoring platform simplifies decision-making in hospital OR and ICU facilities. Platform allows patient data to be displayed on choice of several different screens, which use color-coding and physiologic representation of cardiovascular circulation to reflect patient status and aid decision-making. Functionality facilitates...

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Communication Systems & Equipment

Oxygenation Saturation Monitor uses fiber optics.

Designed specifically for children, PediaSat Oximetry Catheter provides real-time continuous ScvO2 monitoring. Central venous catheter uses fiber optics to monitor and identify potentially life-threatening changes in oxygen-saturation of venous blood in critically ill patients. Catheter is suitable for children with congenital heart disease, complex cardiac conditions, sepsis and septic shock,...

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Company News

Edwards Prevails In U.S. Patent Office Review that Finds Boston Scientific Transcatheter Valve Patent Claims Invalid

WASHINGTON, March 23, 2018 - Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the United States Patent and Trademark Office (USPTO) decided in Edwards' favor in an Inter Partes Review (IPR) of Boston Scientific's U.S. transcatheter heart valve patent, number...

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Company News

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 leaflet mobility of both the...

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Company News

Edwards' Acumen Hypotension Prediction Index Launches In The U.S.

IRVINE, Calif., March 19, 2018 - Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the U.S. Food and Drug Administration granted the De Novo request for Edwards' Acumen Hypotension Prediction Index (HPI) software. The company will initiate a targeted launch of this...

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Fluid & Gas Flow Equipment

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 »
Company News

Edwards Lifesciences to Present at the 36th Annual J.P. Morgan Healthcare Conference

IRVINE, Calif., Jan. 2, 2018 - Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, is scheduled to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco on Monday, January 8, 2018. Michael A. Mussallem, chairman and chief executive officer, is scheduled to...

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Controls & Controllers

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...

Read More »
Mergers & Acquisitions

Edwards Lifesciences Corporation Completes Acquisition of CardiAQ

IRVINE, Calif. - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has closed its acquisition of CardiAQ Valve Technologies, Inc., a privately held company and developer of a transcatheter mitral valve replacement system. Edwards announced last month that it had signed an agreement to acquire CardiAQ....

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Mergers & Acquisitions

Edwards Lifesciences Enters Into Agreement to Acquire CardiAQ

IRVINE, Calif. – Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has agreed to acquire CardiAQ Valve Technologies, Inc., a privately held company and developer of a transcatheter mitral valve replacement system. Edwards' primary strategy is to create valuable therapies that transform patient...

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Communication Systems & Equipment

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 »
Fluid & Gas Flow Equipment

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...

Read More »

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