Edwards Lifesciences Corporation
Company typePublic
IndustryMedical technology[1]
Founded1958; 66 years ago (1958)
HeadquartersIrvine, California, U.S.
Area served
Worldwide
Key people
Bernard J. Zovighian
(CEO)
Products
Revenue$5.2 billion (2021)[2]
Number of employees
14,000 (2020[3])
Websiteedwards.com

Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter.[4] The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore;[5] and is building a new facility due to be completed in 2021 in Limerick, Ireland.[6]

History

Edwards was originally founded by engineer Miles “Lowell” Edwards in 1958.[7] 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.[8] As a result of the successful heart surgery, Edwards Laboratories was founded in Santa Ana, California that same year.[9]

Edwards was acquired by Baxter in 1985. It was spun off from Baxter in 2000.[10]

On January 25, 2017, Edwards completed the acquisition of Valtech Cardio for $340 million. The deal had been first announced the previous November.[11]

On December 6, 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[12] to treat degenerative mitral regurgitation. At the time of the acquisition, the product was not available on any market.[13]

On April 18, 2019, Edwards completed the acquisition of CAS Medical Systems of Branford, Connecticut for ~$100 million.[14]

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.[15] These products are used to treat patients with severe aortic stenosis without utilizing open-heart surgery.[16]

On September 29, 2020, Edwards co-sponsored the Virtual ISPOR-FDA Summit centred on patient preference information in medical device regulatory decisions.[17]

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.[18][19]

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.[20][self-published source?]

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.[21] The indication was expanded in November 2012 to include patients at a high risk for death or serious complications associated with open-heart surgery.[22]

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.[23] Many of these technologies are in early development and clinical phases, with seven programs and four clinical trials.[24]

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.[25]

COVID-19

An analysis powered by the CardioCare program (a part of Edwards Healthcare Solutions) shows 49.9% decline in echocardiography exams,[26] 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.[27]

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.[27][28]

References

  1. ^ "Edwards Lifesciences shares fall on Street-beating Q1 results". 26 April 2022.
  2. ^ "EDWARDS LIFESCIENCES REPORTS FOURTH QUARTER RESULTS 2021" (PDF). Edwards.com. January 26, 2021.
  3. ^ "Edwards Lifesciences' staff kitchen plates up meals for the homeless". The Orange County Register. April 26, 2020.
  4. ^ "Edwards SAPIEN 3 Transcatheter Heart Valve - P140031/S028". FDA. October 24, 2017.
  5. ^ "Locations". Edwards Lifesciences. Retrieved 2020-01-03.
  6. ^ Kennedy, John (2019-04-05). "Edwards Lifesciences to create 600 extra jobs in Limerick". Siliconrepublic.com. Archived from the original on 2019-04-08. Retrieved 2020-01-03.
  7. ^ "Louis Vuitton's flexible-screen handbags are the definition of extra". Oregon Health & Science University. 10 May 2019. Retrieved January 26, 2020.
  8. ^ Annette M. Matthews (February 1999). "The development of the Starr-Edwards heart valve". Texas Heart Institute Journal.
  9. ^ "Miles Lowell Edwards (1898-1982)". The Oregon Encyclopedia. January 27, 2020.
  10. ^ "Baxter To Spin-Off New Cardiovascular Company -- Edwards Lifesciences". Pharmaceutical Online. January 19, 2000.
  11. ^ "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.
  12. ^ 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.
  13. ^ "Harpoon Medical acquired by Edwards". CardiovascularNews.com. 2017-12-08. Archived from the original on 2020-01-05. Retrieved 2020-01-04.
  14. ^ "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.
  15. ^ "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. Retrieved 2019-12-30.
  16. ^ "Edwards Lifesciences' (EW) SAPIEN 3 TAVR Receives FDA Nod". Yahoo! Finance. Zacks. 2019-08-19. Retrieved 2020-01-04.
  17. ^ "ISPOR-FDA Summit 2020". ISPOR. Archived from the original on 2022-06-15. Retrieved 2022-06-15.
  18. ^ "The 2018 Top 30 Global Medical Device Companies". Medical Product Outsourcing. July 26, 2018.
  19. ^ "Wait For The Pullback To Buy Edwards Lifesciences". Seeking Alpha. April 28, 2020.
  20. ^ "Heart valve therapies". Edwards Lifesciences. Retrieved January 30, 2020.
  21. ^ "FDA approval for Edwards' Sapien device is a first for the U.S. market". MassDevice. November 3, 2011.
  22. ^ "FDA Approves The Sapien Transcatheter Heart Valve For High Risk Patients". CardioBrief. October 19, 2012.
  23. ^ "Analysts cool expectations for Edwards' mitral performance". MedTech Dive. December 6, 2019.
  24. ^ "Edwards rolls out 2020 guidance with TAVR optimism, slow pace on mitral and tricuspid". BioWorld. December 6, 2019.
  25. ^ "#15 Edwards Lifesciences". Forbes. May 15, 2019.
  26. ^ "Declining echo exams during COVID-19 may have staggering consequences". August 28, 2020.
  27. ^ a b "Edwards expands its Every Heartbeat Matters initiative". Cardiovascular News. February 21, 2020.
  28. ^ "Edwards Lifesciences' Every Heartbeat Matters is Expanding". MPO. February 21, 2020.

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