Edwards Lifesciences is an American medical technology company headquartered in Irvine,

California California is a U.S. state, state in the Western United States, located along the West Coast of the United States, Pacific Coast. With nearly 39.2million residents across a total area of approximately , it is the List of states and territori ...

, specializing in artificial

heart valves A heart valve is a one-way valve that allows blood to flow in one direction through the chambers of the heart. Four valves are usually present in a mammalian heart and together they determine the pathway of blood flow through the heart. A heart v ...

and

hemodynamic Hemodynamics or haemodynamics are the dynamics of blood flow. The circulatory system is controlled by homeostatic mechanisms of autoregulation, just as hydraulic circuits are controlled by control systems. The hemodynamic response continuously mo ...

monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via

catheter In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Cath ...

. The company has manufacturing facilities at the Irvine headquarters, as well as in

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Utah Utah ( , ) is a state in the Mountain West subregion of the Western United States. Utah is a landlocked U.S. state bordered to its east by Colorado, to its northeast by Wyoming, to its north by Idaho, to its south by Arizona, and to it ...

;

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; the

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;

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; and

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; and is building a new facility due to be completed in 2021 in

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History

Edwards was originally founded by engineer Miles “Lowell” Edwards in 1958. Edwards and Dr. Albert Starr, a surgeon at the University of Oregon Medical School, designed, developed, tested and successfully placed in a patient the first Starr-Edwards mitral valve in 1960. As a result of the successful heart surgery, Edwards Laboratories was founded in

Santa Ana, California Santa Ana () is the second most populous city and the county seat of Orange County, California. Located in the Greater Los Angeles region of Southern California, the city's population was 310,227 at the 2020 census, making Santa Ana the List of ...

that same year. Edwards was acquired by Baxter in 1985. It was spun off from Baxter in 2000. On January 25, 2017, Edwards completed the acquisition of Valtech Cardio for $340 million. The deal had been first announced the previous November. On December 6, 2017, Edwards acquired Harpoon Medical of

Baltimore Baltimore ( , locally: or ) is the List of municipalities in Maryland, most populous city in the U.S. state of Maryland, fourth most populous city in the Mid-Atlantic (United States), Mid-Atlantic, and List of United States cities by popula ...

Maryland Maryland ( ) is a state in the Mid-Atlantic region of the United States. It shares borders with Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware and the Atlantic Ocean to ...

for $100 million. Harpoon, founded in 2013, developed a minimally invasive heart surgery product for

mitral valve repair Mitral valve repair is a cardiac surgery procedure performed by cardiac surgeons to treat stenosis (narrowing) or regurgitation (leakage) of the mitral valve. The mitral valve is the "inflow valve" for the left side of the heart. Blood flows f ...

to treat degenerative mitral regurgitation. At the time of the acquisition, the product was not available on any market. On April 18, 2019, Edwards completed the acquisition of CAS Medical Systems of Branford,

Connecticut Connecticut () is the southernmost state in the New England region of the Northeastern United States. It is bordered by Rhode Island to the east, Massachusetts to the north, New York to the west, and Long Island Sound to the south. Its cap ...

for ~$100 million. Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve systems were

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

-approved for the treatment of patients at low risk for death or major complications associated with open-heart surgery on August 16, 2019. These products are used to treat patients with severe

aortic stenosis Aortic stenosis (AS or AoS) is the narrowing of the exit of the left ventricle of the heart (where the aorta begins), such that problems result. It may occur at the aortic valve as well as above and below this level. It typically gets worse ov ...

without utilizing open-heart surgery. On September 29, 2020, Edwards co-sponsored the Virtual

ISPOR ISPOR—The Professional Society for Health Economics and Outcomes Research, better known as ISPOR (formerly, the International Society for Pharmacoeconomics and Outcomes Research), is a nonprofit global professional organization in health economi ...

Summit centred on patient preference information in

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

regulatory decisions.

Business segments

Its products are categorized into four areas: Surgical Valve Technologies, Transcatheter Heart Valves (THV), Transcatheter Mitral and Tricuspid Therapies (TMTT), and Critical Care.

Surgical Valve Technologies

The portfolio also includes a diverse line of cardiac surgery systems used during minimally invasive surgical procedures, as well as cannulae and other products used during cardiopulmonary bypass.

Transcatheter Heart Valve (THV)

Edwards introduced the transcatheter heart valve (THV) replacement procedure to U.S. patients unable to undergo open-heart surgery with FDA approval of the SAPIEN transcatheter valve in 2011. The indication was expanded in November 2012 to include patients at a high risk for death or serious complications associated with open-heart surgery.

Transcatheter Mitral and Tricuspid Therapies (TMTT)

The Transcatheter Mitral and Tricuspid Therapies business segment involves the research and development of transcatheter heart valve repair and replacement technologies designed to treat mitral and tricuspid valve diseases. Many of these technologies are in early development and clinical phases, with seven programs and four clinical trials.

Critical Care

The Critical Care business segment includes pulmonary artery catheters, disposable pressure transducers and advanced hemodynamic monitoring systems. The portfolio also includes a line of balloon catheter-based vascular products, surgical clips and inserts.

COVID-19

An analysis powered by the CardioCare program (a part of Edwards Healthcare Solutions) shows 49.9% decline in echocardiography exams, which may lead to underdiagnosis of severe aortic stenosis.

Organizational culture

Edwards Lifesciences Foundation

The Edwards Lifesciences Foundation launched in 2014 and supports programs designed to treat underserved people to reduce heart valve disease. The “Every Heartbeat Matters” (EHM) initiative has educated, screened and treated 1.7 million underserved people, exceeding its goal of serving 1 million underserved patients.

References

External links

* {{Authority control Medical technology companies of the United States Companies listed on the New York Stock Exchange Life sciences industry Health care companies based in California Technology companies based in Greater Los Angeles Manufacturing companies based in California Technology companies established in 1958 Manufacturing companies established in 1958 1958 establishments in California