Jump to content

Edwards Lifesciences

From Wikipedia, the free encyclopedia
Edwards Lifesciences Corporation
TypePublic
IndustryMedical technology
Founded1958; 68 years ago (1958)
HeadquartersIrvine, California, U.S.
Area served
Worldwide
Key people
Bernard J. Zovighian (CEO)
Products
  • Heart valves
  • Surgical valve technologies
  • Implantable heart failure management
RevenueIncrease US$6.07 billion (2025)
Decrease US$1.26 billion (2025)
Decrease US$1.07 billion (2025)
Total assetsIncrease US$13.7 billion (2025)
Total equityIncrease US$10.3 billion (2025)
Number of employees
16,000 (2025)
Websiteedwards.com
Footnotes
[1]

Edwards Lifesciences Corporation is an American medical technology company headquartered in Irvine, California, specializing in tissue heart valves and transcatheter technologies for the treatment of structural heart disease.[2][3] The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; Singapore; and Limerick, Ireland.[4][5][6] The company is also constructing a manufacturing plant in Moncada, near Valencia, Spain, with a €150 million investment. Production is scheduled to begin in 2027.[7]

History

[edit]
The Starr-Edwards caged ball valve.

Edwards Lifesciences was originally founded by electrical engineer Miles "Lowell" Edwards in 1958, a graduate of Oregon State University.[8] Edwards invented the first medically proven and adopted artificial heart valve. Dr. Albert Starr, a surgeon at the Oregon Health and Sciences University, is credited as the first to successfully implant the Starr-Edwards mitral valve in a patient in 1960.[9] As a result of the successful heart implant, Edwards established manufacturing in Santa Ana, California the same year to continue his research in pulmonary devices.[10]

Edwards' valves are still in operation today. An early patient lived a record 48 years with the implant before requiring a replacement.[11]

Edwards was acquired by Baxter in 1985. It was spun off from Baxter in 2000.[12]

In 2017, Edwards completed the acquisition of Valtech Cardio for $340 million.[13] Also in 2017, Edwards acquired Harpoon Medical of Baltimore, Maryland for $100 million. Harpoon, founded in 2013, developed a minimally invasive heart surgery product for mitral valve repair[14] to treat degenerative mitral regurgitation. At the time of the acquisition, the product was not available on any market.[15]

On April 18, 2019, Edwards completed the acquisition of CAS Medical Systems of Branford, Connecticut for ~$100 million.[16]

Edwards Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valve systems were FDA-approved for the treatment of patients at low risk for death or major complications associated with open-heart surgery on August 16, 2019.[17] These products are used to treat patients with severe aortic stenosis without utilizing open-heart surgery.[18]

In 2020, Edwards co-sponsored the Virtual ISPOR-FDA Summit centered on patient preference information in medical device regulatory decisions.[19]

In December 2021, the FDA approved the SAPIEN 3 transcatheter valve in combination with the Alterra adaptive prestent for the treatment of severe pulmonary regurgitation.[20][21]

In February 2024, the FDA approved Edwards' EVOQUE tricuspid valve replacement system, the first transcatheter therapy approved in the United States for the treatment of tricuspid regurgitation.[22][23] In May 2024, Edwards launched the SAPIEN 3 Ultra RESILIA valve in Europe.[24]

In June 2024, the company received FDA approval for a new implant designed to manage heart failure issues, called the Cordella pulmonary artery sensor.[25]

In July 2024, Edwards made agreements with Affluent Medical for an equity stake, IP licensing and an exclusive option to acquire its Kephalios subsidiary.[26] The same month, Edwards announced it would acquire Innovalve Bio Medical for approximately $300 million, and JenaValve Technology and Endotronix for $1.2 billion.[27][28]

In August 2024, Edwards acquired JC Medical from Genesis MedTech, gaining its J-Valve transcatheter aortic valve replacement system for the treatment of aortic regurgitation.[29]

In 2023, Edwards announced that its critical care business unit would be spun off into a separate entity. In June 2024 Edwards instead agreed to sell the unit to BD for $4.2 billion. The sale closed on September 3, 2024.[30][31]

In May 2025, the FDA approved the SAPIEN 3 platform, including the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves, for the treatment of severe aortic stenosis in asymptomatic patients, marking the first FDA approval of TAVR therapy for this patient population.[32][33]

In September 2025, Edwards completed the full acquisition of heart failure monitoring company Vectorious Medical Technologies.[34]

In January 2026, the FDA approved the SAPIEN M3 mitral valve replacement system, the first transcatheter mitral valve replacement therapy using a transseptal approach to receive FDA approval for the treatment of mitral regurgitation.[35]

Business segments

[edit]

Prior to September 2024, its products were categorized into four areas: surgical valve technologies, transcatheter heart valves, transcatheter mitral and tricuspid therapies, and critical care.[36][37] In September 2024, Edwards completed the sale of its Critical Care product group to BD.[38] Since September 2024, its products are categorized into four areas: surgical valve technologies, transcatheter heart valves, transcatheter mitral and tricuspid therapies, and implantable heart failure management (IHFM).[39]

Transcatheter Heart Valve

[edit]

The company's SAPIEN family of transcatheter aortic heart valves is made of bovine pericardial tissue mounted within a balloon-expandable, cobalt-chromium frame and is deployed via catheter.[40] Edwards introduced the transcatheter heart valve replacement procedure to U.S. patients unable to undergo open-heart surgery with FDA approval of the SAPIEN transcatheter valve in 2011.[41] The indication was expanded in November 2012 to include patients at a high risk for death or serious complications associated with open-heart surgery.[42] In 2021, the FDA cleared Edwards’ SAPIEN 3 transcatheter valve with the Alterra adaptive prestent for pulmonic heart valve replacement.[43] In May 2024, Edwards launched the SAPIEN 3 Ultra RESILIA valve in Europe.[44]

Transcatheter Mitral and Tricuspid Therapies

[edit]

The Transcatheter Mitral and Tricuspid Therapies business segment develops transcatheter heart valve repair and replacement technologies to treat mitral and tricuspid valve diseases. In September 2022, the FDA approved Edwards' PASCAL Precision transcatheter valve repair system for the treatment of degenerative mitral regurgitation.[45][46][47]

Surgical

[edit]

The Surgical business segment involves the use of Edwards' RESILIA tissue technology, developed to help limit valve calcification. Edwards estimates that more than 450,000 patients around the world have either undergone SAVR or TAVR with an Edwards RESILIA valve.[48]

Critical Care

[edit]

Before its sale, the Critical Care business segment included pulmonary artery catheters, disposable pressure transducers and advanced hemodynamic monitoring systems. The portfolio also included a line of balloon catheter-based vascular products, surgical clips and inserts. In 2023, it was announced that the critical care business unit was to be spun off into its own entity, however in 2024 the critical care department was purchased by BD for $4.2 billion.[49][50]

Organizational culture

[edit]

Edwards Lifesciences Foundation

[edit]

The Edwards Lifesciences Foundation launched in 2014 and supports programs designed to treat underserved people to reduce heart valve disease.[51]

Since the initiative launched in 2014, Edwards and its foundation have contributed more than $100 million in financial and technology donations through "Every Heartbeat Matters" (EHM), reaching over 4 million underserved structural heart patients globally.[52][53][54]

References

[edit]
  1. ↑ "Edwards Lifesciences 2025 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. February 2026.
  2. ↑ Connelly, Frank (2024-06-03). "BD to Buy Edwards Life's Critical Care Unit for $4.2 Billion". Bloomberg.com.
  3. ↑ "Edwards Sapien 3 Transcatheter Heart Valve - P140031/S028". FDA. October 24, 2017. Archived from the original on December 14, 2019.
  4. ↑ "Edwards Lifesciences 2025 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. February 2026.
  5. ↑ "Edwards' Critical Care Unit Remains in Irvine". Orange County Business Journal. October 29, 2024.
  6. ↑ "Edwards Lifesciences celebrates the opening of its Limerick Manufacturing Plant" (Press release). IDA Ireland. October 22, 2021.
  7. ↑ "Edwards Lifesciences to manufacture heart valves in Valencia". ICEX-Invest in Spain. 2024.
  8. ↑ "New OPB documentary profiles the Oregon-based inventors of the first successful artificial heart valve, a breakthrough in cardiac surgery". opb.org. OPB. Retrieved 19 May 2025.
  9. ↑ Annette M. Matthews (February 1999). "The development of the Starr-Edwards heart valve". Texas Heart Institute Journal.
  10. ↑ "Miles Lowell Edwards (1898-1982)". The Oregon Encyclopedia. January 27, 2020.
  11. ↑ Dimitrakakis, Georgios (2021). "Starr–Edwards mitral valve—48 years till redo surgery, with over 54 years of patient survival after primary mitral valve replacement". Interactive Cardiovascular and Thoracic Surgery. 33 (4). National Institutes of Health: 640–642. doi:10.1093/icvts/ivab131. PMC 8691538. PMID 33954795.
  12. ↑ "Baxter To Spin-Off New Cardiovascular Company -- Edwards Lifesciences". Pharmaceutical Online. January 19, 2000.
  13. ↑ "Edwards Lifesciences Completes Acquisition of Valtech Cardio". Diagnostic and Interventional Cardiology (DAIC). 2017-01-25. Archived from the original on 2017-01-29. Retrieved 2020-01-04.
  14. ↑ Gantz, Sarah (2017-12-06). "Baltimore-based Harpoon Medical acquired for $100 million". Archived from the original on 2018-10-25. Retrieved 2020-01-04.
  15. ↑ "Harpoon Medical acquired by Edwards". CardiovascularNews.com. 2017-12-08. Archived from the original on 2020-01-05. Retrieved 2020-01-04.
  16. ↑ "Edwards Lifesciences Completes Acquisition of CASMED". MarketWatch.com. PR Newswire. 2019-04-18. Archived from the original on 2020-01-04. Retrieved 2020-01-03.
  17. ↑ "Edwards Sapien 3 Transcatheter Heart Valve System and Edwards Sapien 3 Ultra Transcatheter Heart Valve System - P140031/S085". FDA.gov. U.S. Food & Drug Administration. 2019-08-16. Archived from the original on September 11, 2019. Retrieved 2019-12-30.
  18. ↑ "Edwards Lifesciences' (EW) Sapien 3 TAVR Receives FDA Nod". Yahoo! Finance. Zacks. 2019-08-19. Retrieved 2020-01-04.
  19. ↑ "ISPOR-FDA Summit 2020". ISPOR. Retrieved 2022-06-15.{{cite web}}: CS1 maint: deprecated archival service (link)
  20. ↑ "FDA Clears SAPIEN 3 With Alterra Prestent for Pulmonary Valve Replacement". TCTMD. December 20, 2021.
  21. ↑ "PASCAL Precision Transcatheter Valve Repair System". U.S. Food and Drug Administration. September 14, 2022.
  22. ↑ "Edwards EVOQUE Tricuspid Valve Replacement System – P230013". U.S. Food and Drug Administration. February 1, 2024.
  23. ↑ "Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment". MedTech Dive. February 2, 2024.
  24. ↑ "Edwards launches Sapien 3 Ultra Resilia TAVR in Europe". MassDevice. May 10, 2024.
  25. ↑ "FDA Approves Cordella Remote PA Pressure Monitoring System for HF". TCTMD.com. Archived from the original on 2026-03-09. Retrieved 2026-05-29.
  26. ↑ Whooley, Sean (2024-07-12). "Affluent Medical signs $16.3M mitral valve deals with Edwards". MassDevice. Retrieved 2024-07-30.
  27. ↑ Silverwood, Joshua (2024-07-16). "Edwards Lifesciences buys mitral valve business Innovalve in $300m deal". Medical Device Network. Retrieved 2024-07-30.
  28. ↑ Newmarker, Chris (2024-07-25). "Edwards Lifesciences to spend $1.2B on two more M&A deals". MassDevice. Retrieved 2024-07-30.
  29. ↑ Whooley, Sean (August 19, 2024). "Edwards acquires valve maker JC Medical". MassDevice.
  30. ↑ Connelly, Frank (June 3, 2024). "BD to Buy Edwards Life's Critical Care Unit for $4.2 Billion". Bloomberg.
  31. ↑ Whooley, Sean (September 3, 2024). "BD closes $4.2B Edwards Lifesciences critical care acquisition". MassDevice.
  32. ↑ "Edwards gains expanded TAVR label for asymptomatic patients". MedTech Dive. May 5, 2025.
  33. ↑ "FDA Update: Agency Approves TAVR Valves For Asymptomatic Severe AS". American College of Cardiology. May 1, 2025.
  34. ↑ Whooley, Sean (September 4, 2025). "Edwards buys remaining stake of Vectorious Medical Technologies and its heart implant". MassDevice.
  35. ↑ O'Riordan, Michael (December 23, 2025). "FDA Approves Sapien M3 for Transseptal Mitral Valve Replacement". TCTMD.
  36. ↑ "The 2018 Top 30 Global Medical Device Companies". Medical Product Outsourcing. July 26, 2018.
  37. ↑ "Wait For The Pullback To Buy Edwards Lifesciences". Seeking Alpha. April 28, 2020.
  38. ↑ Whooley, Sean (September 3, 2024). "BD closes $4.2B Edwards Lifesciences critical care acquisition". MassDevice.
  39. ↑ "ew-20251231". www.sec.gov. Retrieved 2026-05-21.
  40. ↑ "Edwards Sapien 3 Transcatheter Heart Valve - P140031/S028". FDA. October 24, 2017. Archived from the original on December 14, 2019.
  41. ↑ "FDA approval for Edwards' Sapien device is a first for the U.S. market". MassDevice. November 3, 2011.
  42. ↑ "FDA Approves The Sapien Transcatheter Heart Valve For High Risk Patients". CardioBrief. October 19, 2012.
  43. ↑ "FDA Clears SAPIEN 3 With Alterra Prestent for Pulmonary Valve Replacement". tctmd.com.
  44. ↑ Whooley, Sean (2024-05-09). "Edwards launches Sapien 3 Ultra Resilia TAVR in Europe". MassDevice. Retrieved 2026-05-29.
  45. ↑ "PASCAL Precision Transcatheter Valve Repair System". U.S. Food and Drug Administration. September 14, 2022.
  46. ↑ "Edwards rolls out 2020 guidance with TAVR optimism, slow pace on mitral and tricuspid". BioWorld. December 6, 2019.
  47. ↑ "Analysts cool expectations for Edwards' mitral performance". MedTech Dive. December 6, 2019.
  48. ↑ "Resilia tissue developed by Edwards Lifesciences linked to long-term benefits". cardiovascularbusiness.
  49. ↑ Connelly, Frank (2024-06-03). "BD to Buy Edwards Life's Critical Care Unit for $4.2 Billion". Bloomberg.com. Retrieved 2024-07-30.
  50. ↑ "#15 Edwards Lifesciences". Forbes. May 15, 2019.
  51. ↑ "Edwards expands its Every Heartbeat Matters initiative". Cardiovascular News. February 21, 2020.
  52. ↑ "Edwards Lifesciences Advances Structural Heart Care Through Innovation and Purpose". Archived from the original on 2026-03-11. Retrieved 2026-05-21.
  53. ↑ O'Neill, Angela (2020-02-21). "Edwards expands its Every Heartbeat Matters initiative". Cardiovascular News. Retrieved 2026-05-21.
  54. ↑ "Edwards Lifesciences' Every Heartbeat Matters is Expanding". Medical Product Outsourcing. 2020-02-21. Retrieved 2026-05-21.
[edit]
Retrieved from "https://en.wikipedia.org/w/index.php?title=Edwards_Lifesciences&oldid=1364172810"