Edwards Lifesciences
Corporate brand
UnclaimedA medical technology company specializing in heart valves, transcatheter therapies, and implantable monitoring technologies for structural heart disease.
Last updated August 31, 2026
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Overview
Edwards Lifesciences is a United States-based medical technology company focused on structural heart disease and related cardiovascular conditions. Its principal areas of activity are surgical heart valves, transcatheter heart valve replacement, transcatheter mitral and tricuspid therapies, and implantable technologies for heart-failure management. The company is particularly associated with the SAPIEN family of transcatheter aortic heart valves, which helped establish transcatheter aortic valve replacement, or TAVR, as an important alternative to open-heart surgery for selected patients with aortic stenosis. The company traces its origins to electrical engineer Miles Lowell Edwards, who founded the business in 1958 after developing an artificial heart valve. In 1960, surgeon Albert Starr successfully implanted the Starr-Edwards mitral valve, an event that helped demonstrate the clinical potential of prosthetic heart-valve treatment and led Edwards to establish manufacturing operations in California. Edwards valves have remained implanted in patients for decades, including an early patient whose valve reportedly functioned for 48 years before replacement was required. Edwards was acquired by Baxter in 1985 and operated within that company until it was spun off as an independent public company in 2000. As an independent company, Edwards concentrated increasingly on cardiovascular devices and built a broad portfolio around tissue valves, minimally invasive procedures, and monitoring systems. Its SAPIEN transcatheter valve received United States approval in 2011 for patients who were unable to undergo open-heart surgery; the indication was expanded in 2012 to include patients considered at high risk from conventional surgery. Subsequent generations extended the platform's use across additional patient groups and anatomical settings. The company's surgical portfolio includes tissue valves using RESILIA technology, which is designed to improve durability by limiting calcification. Its transcatheter portfolio includes balloon-expandable aortic valves, pulmonary valve solutions, and newer replacement and repair technologies for the mitral and tricuspid valves. The PASCAL system addresses mitral regurgitation through catheter-based repair, while EVOQUE is a transcatheter tricuspid replacement system. Edwards has also developed implantable monitoring technologies for heart-failure management, including the Cordella pulmonary artery sensor. Edwards expanded through targeted acquisitions and partnerships. In 2017 it acquired Valtech Cardio and Harpoon Medical, adding mitral and tricuspid repair capabilities. It acquired CAS Medical Systems in 2019, strengthening its monitoring portfolio. In 2024, the company announced or completed several transactions involving heart-valve and heart-failure technologies, including Innovalve Bio Medical, JenaValve Technology, Endotronix, JC Medical, and arrangements involving Affluent Medical and its Kephalios subsidiary. In contrast, Edwards divested its Critical Care business to Becton, Dickinson and Company in 2024 after previously considering a spin-off. Before the divestiture, Critical Care included pulmonary artery catheters, pressure transducers, and advanced hemodynamic-monitoring systems. After the transaction closed in September 2024, Edwards organized its business around surgical valve technologies, transcatheter heart valves, transcatheter mitral and tricuspid therapies, and implantable heart-failure management. The company manufactures in the United States and internationally, with facilities reported in California, Utah, Costa Rica, Singapore, and Ireland, and has announced a manufacturing project near Valencia, Spain. Edwards also operates philanthropic programs through the Edwards Lifesciences Foundation and the Every Heartbeat Matters initiative, which support access to care for underserved structural-heart patients.
History
Edwards Lifesciences began in 1958 when electrical engineer Miles Lowell Edwards established a company to develop artificial heart valves. Edwards' work led to the Starr-Edwards valve, developed with surgeon Albert Starr. In 1960, Starr successfully implanted the company's mitral valve in a patient, helping establish prosthetic valve replacement as a viable clinical treatment. Edwards established manufacturing in Santa Ana, California, during the same year and continued developing cardiovascular and pulmonary devices. The company's early valve technology became a foundation for later tissue-valve and minimally invasive cardiovascular products. Some early Edwards valves remained in service for many years; one reported patient used an implanted valve for 48 years before requiring replacement. In 1985, Baxter acquired Edwards, and the business operated within Baxter until its separation in 2000. The spin-off allowed Edwards to operate as an independent public medical-technology company with a strong concentration on cardiovascular disease. During the 2000s and 2010s, Edwards increasingly shifted toward tissue valves and catheter-based interventions. Its SAPIEN program helped bring TAVR into routine clinical practice in the United States. FDA approval in 2011 initially addressed patients unable to undergo open-heart surgery, while a 2012 expansion covered patients at high surgical risk. Later SAPIEN generations broadened the patient population and added applications beyond conventional aortic replacement, including pulmonary-valve treatment when paired with the Alterra prestent. Edwards supplemented internal development with acquisitions. In 2017 it acquired Valtech Cardio, expanding its mitral and tricuspid repair capabilities, and Harpoon Medical, which was developing a minimally invasive mitral-repair technology. The acquisition of CAS Medical Systems in 2019 added monitoring products. The company also continued investing in surgical tissue valves, including RESILIA technology designed to reduce calcification and support valve durability. Its catheter-based mitral and tricuspid portfolio advanced with the PASCAL repair system and the EVOQUE replacement system. PASCAL Precision received FDA approval in 2022 for degenerative mitral regurgitation. In 2024, EVOQUE received FDA approval for tricuspid regurgitation and became the first transcatheter tricuspid replacement therapy approved in the United States. Edwards also introduced the SAPIEN 3 Ultra RESILIA valve in Europe and received FDA authorization for the Cordella pulmonary artery sensor for heart-failure monitoring. Edwards changed its organizational structure in 2024. The company had previously announced a plan to spin off Critical Care, whose products included pulmonary artery catheters, pressure transducers, and hemodynamic monitoring systems. Instead, it sold the business to BD, with the transaction closing on September 3, 2024. Following the divestiture, Edwards' principal areas became surgical valve technologies, transcatheter heart valves, transcatheter mitral and tricuspid therapies, and implantable heart-failure management. In parallel, Edwards pursued additional structural-heart and heart-failure assets. Its 2024 transactions included agreements with Affluent Medical and acquisitions or announced acquisitions involving Innovalve Bio Medical, JenaValve Technology, Endotronix, and JC Medical. The company later completed the acquisition of Vectorious Medical Technologies in 2025. Its manufacturing footprint includes facilities in California, Utah, Costa Rica, Singapore, and Ireland, and it has announced a new facility near Valencia, Spain. Through the Edwards Lifesciences Foundation and Every Heartbeat Matters, the company also supports programs intended to expand access to treatment for underserved structural-heart patients.
- 2026
SAPIEN M3 approved
[1]The FDA approved the SAPIEN M3 transseptal transcatheter mitral valve replacement system for mitral regurgitation.
- 2025
SAPIEN platform expanded to asymptomatic patients
[1]The FDA approved the SAPIEN 3 platform for selected asymptomatic patients with severe aortic stenosis.
- 2024
EVOQUE approved and Critical Care divested
[1]EVOQUE received FDA approval for tricuspid regurgitation, while Edwards completed the sale of Critical Care to BD.
- 2022
PASCAL Precision approved
[1]The FDA approved PASCAL Precision for catheter-based repair of degenerative mitral regurgitation.
- 2021
SAPIEN 3 with Alterra cleared for pulmonary use
[1]The FDA cleared the SAPIEN 3 valve with Alterra for severe pulmonary regurgitation.
- 2019
CAS Medical Systems acquisition completed
[1]The acquisition added medical monitoring technologies to Edwards' portfolio.
- 2017
Valtech Cardio and Harpoon Medical acquisitions
[1]Edwards acquired two companies to strengthen its catheter-based and minimally invasive mitral and tricuspid therapy capabilities.
- 2012
SAPIEN indication expands to high-surgical-risk patients
[1]The FDA expanded the indication to include patients at high risk of death or serious complications from open-heart surgery.
- 2011
SAPIEN receives initial United States approval
[1]The FDA approved the SAPIEN transcatheter valve for patients unable to undergo open-heart surgery.
- 2000
Spun off from Baxter
[1]Edwards became an independent public company after being separated from Baxter.
Products and positioning
A specialist cardiovascular medical-technology leader focused on minimally invasive structural-heart treatment, durable tissue valves, and clinically integrated heart-failure technologies.
Transcatheter aortic and pulmonary heart valves · 2011
SAPIEN transcatheter heart valve family
The SAPIEN family consists primarily of balloon-expandable transcatheter valves using bovine pericardial tissue mounted within a cobalt-chromium frame. Delivered through a catheter, the valves are designed to replace diseased valves without conventional open-heart surgery in appropriate patients. The portfolio includes SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA systems, with indications expanded over time across risk groups and selected pulmonary applications.
Surgical tissue valves
RESILIA tissue technology
RESILIA is Edwards' tissue-processing technology for surgical and transcatheter valves. It is intended to limit calcification, a process that can impair the performance of biological valve tissue. The technology is used across Edwards' tissue-valve portfolio and supports the company's positioning around durability and long-term cardiovascular treatment.
Transcatheter mitral repair · 2022
PASCAL Precision
PASCAL Precision is a catheter-based valve-repair system for mitral regurgitation. It uses an implant delivered through a transcatheter procedure to approximate and stabilize valve leaflets, reducing backward blood flow. The system is intended to provide a minimally invasive option for selected patients with degenerative mitral valve disease.
Transcatheter tricuspid replacement · 2024
EVOQUE
EVOQUE is a transcatheter tricuspid valve replacement system designed for patients with tricuspid regurgitation. It is delivered through a catheter and replaces the native tricuspid valve rather than relying solely on leaflet repair. Its United States approval in 2024 marked a significant regulatory milestone for transcatheter treatment of tricuspid disease.
Implantable heart-failure management · 2024
Cordella pulmonary artery sensor
Cordella is an implantable pulmonary artery pressure sensor intended to support heart-failure management. The device enables clinicians to monitor pressure-related information that can help guide ongoing care and treatment decisions. It forms part of Edwards' post-2024 implantable heart-failure management focus.
Hemodynamic monitoring
Critical Care monitoring portfolio
Before its sale to BD, Edwards' Critical Care portfolio included pulmonary artery catheters, disposable pressure transducers, advanced hemodynamic-monitoring systems, and related vascular and surgical products. The business supported monitoring of critically ill patients but is no longer part of Edwards' operating portfolio after the 2024 divestiture.
Marketing campaigns
- 2014Every Heartbeat Matters
Global
Edwards and the Edwards Lifesciences Foundation launched Every Heartbeat Matters to support programs improving access to structural-heart diagnosis, treatment, training, and care for underserved populations.
Outcome. The initiative and related foundation programs have been reported as reaching millions of underserved structural-heart patients and receiving more than $100 million in combined financial and technology contributions.
Brand decisions
2026
Launch SAPIEN M3 mitral replacement systemProduct launchBackground
Edwards continued developing transcatheter alternatives for patients with mitral regurgitation who may require valve replacement.
Action taken
The FDA approved SAPIEN M3, described in the reference material as the first transseptal transcatheter mitral valve replacement therapy approved in the United States for mitral regurgitation.
Aftermath
The approval expanded Edwards' transcatheter replacement portfolio from aortic and tricuspid applications into mitral valve replacement.
2025
Expand SAPIEN 3 platform to asymptomatic severe aortic stenosisProduct launchBackground
Edwards sought to extend TAVR into an earlier stage of severe aortic stenosis for appropriately selected patients.
Action taken
The FDA approved the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA platforms for selected asymptomatic patients.
Aftermath
The decision created a new United States indication for TAVR in an asymptomatic patient population.
2024
Sell Critical Care to BDM&ABackground
Edwards decided to exit Critical Care and concentrate on structural-heart and implantable heart-failure technologies.
Action taken
It agreed to sell the Critical Care product group to Becton, Dickinson and Company; the transaction closed on September 3, 2024.
Aftermath
Edwards' post-transaction business structure centered on surgical valves, transcatheter heart valves, mitral and tricuspid therapies, and implantable heart-failure management.
Reported transaction value. $4.2 billion (2024)
2024
Expand into additional structural-heart and heart-failure technologiesM&ABackground
Edwards pursued complementary technologies in aortic valve replacement, mitral and tricuspid treatment, and heart-failure monitoring.
Action taken
The company announced transactions involving Affluent Medical, Innovalve Bio Medical, JenaValve Technology, Endotronix, and JC Medical.
Aftermath
These transactions broadened Edwards' development and commercial pipeline beyond its established SAPIEN and surgical-valve franchises.
2023
Plan to separate Critical CareStrategyBackground
Edwards intended to sharpen its strategic focus on structural heart disease while separating its critical-care monitoring business.
Action taken
The company announced that Critical Care would be spun off into a separate entity.
Aftermath
The planned spin-off was replaced by an agreement to sell the business to BD in 2024.
2017
Acquire Valtech Cardio and Harpoon MedicalM&ABackground
Edwards sought to broaden its minimally invasive structural-heart capabilities beyond aortic valve replacement.
Action taken
It completed the acquisition of Valtech Cardio and acquired Harpoon Medical, whose technology addressed mitral-valve repair.
Aftermath
The transactions strengthened Edwards' presence in mitral and tricuspid repair and replacement technologies.
Recent events
FDA approves PASCAL Precision for tricuspid valve repair[3]
The U.S. Food and Drug Administration approved Edwards Lifesciences’ PASCAL Precision system for tricuspid valve repair.
Reported
Providence and Edwards Lifesciences partner on vaccination clinics[4]
Providence partnered with Edwards Lifesciences and four Orange County cities to open two mass COVID-19 vaccination clinics. One clinic at an Edwards Lifesciences site opened on April 21, 2021; the second was scheduled to open on April 26.
Sources4 sources
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