Edwards Lifesciences

Edwards Lifesciences is an American medical technology company headquartered in Irvine, CA, specializing in artificial heart valves and hemodynamic monitoring. It is most well-known for its SAPIEN transcatheter aortic heart valve made of bovine tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter.[3] It is the first such FDA-approved, commercially-available device to replace a defective aortic valve without the need for open-heart surgery.[4][5]

Edwards Lifesciences Corporation
Public
Traded as
ISINUS28176E1082 
IndustryMedical technology
Founded1958 (1958)
HeadquartersIrvine, California, U.S.
Area served
Worldwide
Key people
Michael A. Mussallem, Chairman & CEO
Products
Revenue$4.3 billion (2019)[1]
Number of employees
14,000 (2020[2])
Websiteedwards.com

The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore;[6] and is building a new facility due to be completed in 2021 in Limerick, Ireland.[7] Edwards' competitors include Boston Scientific and Abbott Laboratories.[8]

History

Edwards was originally founded by engineer Miles “Lowell” Edwards in 1958.[9] 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.[10] As a result of the successful heart surgery, Edwards Laboratories was founded in Santa Ana, California that same year.[11]

In 1966, Edwards Laboratories was purchased by American Hospital Supply Corporation and became American Edwards Laboratories, which was later acquired by Baxter International in 1985.[12][13] On April 3, 2000, Edwards was spun off from Baxter as an independent, publicly held corporation and began trading on the New York Stock Exchange under the symbol “EW”. Edwards now has a presence in approximately 100 countries with 14,000 employees around the world.[2]

On January 25, 2017, Edwards completed the acquisition of Valtech Cardio for $340 million. The deal had been first announced the previous November.[14]

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 [15] to treat degenerative mitral regurgitation. At the time of the acquisition, the product was not available on any market.[16]

On April 18, 2019, Edwards completed the acquisition of CAS Medical Systems of Branford, Connecticut for ~$100 million.[17]

Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve systems were FDA-approved on August 16, 2019.[18] These products are used to treat patients with severe aortic stenosis without utilizing open-heart surgery.[19]

Business Segments

Edwards Lifesciences designs, develops, manufactures, and markets products to treat cardiovascular disease.[20] Its products are categorized into four areas: Surgical Structural Heart, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral and Tricuspid Therapies (TMTT), and Critical Care.[21][22] Edwards serves customers worldwide.[23]

Surgical Structural Heart

The Surgical Structural Heart business segment includes tissue heart valves and heart valve repair products for the surgical replacement or repair of a patient's heart valve. The portfolio also includes a diverse line of cardiac surgery systems used during minimally invasive surgical procedures, as well as cannulae, embolic protection devices and other products used during cardiopulmonary bypass.[24]

Transcatheter Aortic Valve Replacement (TAVR)

The Transcatheter Aortic Valve Replacement business segment includes technologies designed to treat heart valve disease using catheter-based approaches as opposed to open surgical techniques.[20]

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.[25] Many of these technologies are in early development and clinical phases, with seven programs and four clinical trials.[26] The global market for TMTT therapies is expected to reach about $3 billion by 2024.[27]

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.[20]

References
  1. "EDWARDS LIFESCIENCES REPORTS FOURTH QUARTER RESULTS". Edwards.com. January 30, 2020.
  2. "Edwards Lifesciences' staff kitchen plates up meals for the homeless". The Orange County Register. April 26, 2020.
  3. "Edwards SAPIEN 3 Transcatheter Heart Valve - P140031/S028". FDA. October 24, 2017.
  4. MacRae, Michael (2011-12-08). "Visualizing the Sapien Heart Valve". ASME.org. The American Society of Mechanical Engineers.
  5. "FDA expands use of Sapien 3 artificial heart valve for high-risk patients". Food and Drug Administration. June 5, 2017.
  6. "Locations". Edwards Lifesciences. Retrieved 2020-01-03.
  7. 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.
  8. Cohan, Peter (2019-11-29). "Edwards Lifesciences Would Make Peter Drucker Smile". Forbes. Archived from the original on 2019-11-30. Retrieved 2019-12-30.
  9. "Louis Vuitton's flexible-screen handbags are the definition of extra". Oregon Health & Science University. Retrieved January 26, 2020.
  10. Annette M. Matthews (February 1999). "The development of the Starr-Edwards heart valve". Texas Heart Institute Journal.
  11. "Miles Lowell Edwards (1898-1982)". The Oregon Encyclopedia. January 27, 2020.
  12. "Our history". Edwards Lifesciences. Retrieved January 26, 2020.
  13. "Baxter To Spin-Off New Cardiovascular Company -- Edwards Lifesciences". Pharmaceutical Online. January 19, 2000.
  14. "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.
  15. 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.
  16. "Harpoon Medical acquired by Edwards". CardiovascularNews.com. 2017-12-08. Archived from the original on 2020-01-04. Retrieved 2020-01-04.
  17. "Edwards Lifesciences Completes Acquisition of CASMED". MarketWatch.com. PR Newswire. 2019-04-18. Archived from the original on 2020-01-03. Retrieved 2020-01-03.
  18. "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.
  19. "Edwards Lifesciences' (EW) SAPIEN 3 TAVR Receives FDA Nod". Yahoo! Finance. Zacks. 2019-08-19. Retrieved 2020-01-04.
  20. "#15 Edwards Lifesciences". Forbes. May 15, 2019.
  21. "The 2018 Top 30 Global Medical Device Companies". Medical Product Outsourcing. July 26, 2018.
  22. "Wait For The Pullback To Buy Edwards Lifesciences". Seeking Alpha. April 28, 2020.
  23. "Edwards Lifesciences LLC". Bloomberg L.P. January 20, 2020.
  24. "Heart valve therapies". Edwards Lifesciences. Retrieved January 30, 2020.
  25. "Analysts cool expectations for Edwards' mitral performance". MedTech Dive. December 6, 2019.
  26. "Edwards rolls out 2020 guidance with TAVR optimism, slow pace on mitral and tricuspid". BioWorld. December 6, 2019.
  27. "Edwards projects $5 billion in sales for 2020". MassDevice. December 5, 2019.
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