Edwards Lifesciences

Last updated
Edwards Lifesciences Corporation
Company type Public
IndustryMedical technology [1]
Founded1958;66 years ago (1958)
Headquarters Irvine, 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] )
Website edwards.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]

Contents

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. 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 to support their company's market needs. [25] [26]

COVID-19

An analysis powered by the CardioCare program (a part of Edwards Healthcare Solutions) shows 49.9% decline in echocardiography exams, [27] 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. [28]

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. [28] [29]

Related Research Articles

<span class="mw-page-title-main">Interventional cardiology</span> Catheter-based treatment of structural heart diseases

Interventional cardiology is a branch of cardiology that deals specifically with the catheter based treatment of structural heart diseases. Andreas Gruentzig is considered the father of interventional cardiology after the development of angioplasty by interventional radiologist Charles Dotter.

<span class="mw-page-title-main">Mitral regurgitation</span> Form of valvular heart disease

Mitral regurgitation (MR), also known as mitral insufficiency or mitral incompetence, is a form of valvular heart disease in which the mitral valve is insufficient and does not close properly when the heart pumps out blood. It is the abnormal leaking of blood backwards – regurgitation from the left ventricle, through the mitral valve, into the left atrium, when the left ventricle contracts. Mitral regurgitation is the most common form of valvular heart disease.

Aortic valve replacement is a cardiac surgery procedure whereby a failing aortic valve is replaced with an artificial heart valve. The aortic valve may need to be replaced because of aortic regurgitation, or if the valve is narrowed by stenosis.

<span class="mw-page-title-main">Artificial heart valve</span> Replacement of a valve in the human heart

An artificial heart valve is a one-way valve implanted into a person's heart to replace a heart valve that is not functioning properly. Artificial heart valves can be separated into three broad classes: mechanical heart valves, bioprosthetic tissue valves and engineered tissue valves.

<span class="mw-page-title-main">Valvular heart disease</span> Disease in the valves of the heart

Valvular heart disease is any cardiovascular disease process involving one or more of the four valves of the heart. These conditions occur largely as a consequence of aging, but may also be the result of congenital (inborn) abnormalities or specific disease or physiologic processes including rheumatic heart disease and pregnancy.

<span class="mw-page-title-main">Valve replacement</span> Replacement of one or more of the heart valves

Valve replacement surgery is the replacement of one or more of the heart valves with either an artificial heart valve or a bioprosthesis. It is an alternative to valve repair.

<span class="mw-page-title-main">Transcatheter aortic valve replacement</span> Technique for implantation of the aortic valve in a heart

Transcatheter aortic valve implantation (TAVI) is the implantation of the aortic valve of the heart through the blood vessels without actual removal of the native valve. The first TAVI was performed on 16 April 2002 by Alain Cribier, which became a new alternative in the management of high-risk patients with severe aortic stenosis. The implantated valve is delivered via one of several access methods: transfemoral, transapical, subclavian, direct aortic, and transcaval, among others.

Mitral valve replacement is a procedure whereby the diseased mitral valve of a patient's heart is replaced by either a mechanical or tissue (bioprosthetic) valve.

<span class="mw-page-title-main">Lutembacher's syndrome</span> Medical condition

Lutembacher's syndrome is a very rare form of congenital heart disease that affects one of the chambers of the heart as well as a valve. It is commonly known as both congenital atrial septal defect (ASD) and acquired mitral stenosis (MS). Congenital atrial septal defect refers to a hole being in the septum or wall that separates the two atria; this condition is usually seen in fetuses and infants. Mitral stenosis refers to mitral valve leaflets sticking to each other making the opening for blood to pass from the atrium to the ventricles very small. With the valve being so small, blood has difficulty passing from the left atrium into the left ventricle. Septal defects that may occur with Lutembacher's syndrome include: Ostium primum atrial septal defect or ostium secundum which is more prevalent.

David H. Adams is an American cardiac surgeon and the Marie-Josée and Henry R. Kravis Professor and Chairman of the Department of Cardiothoracic Surgery, Icahn School of Medicine at Mount Sinai Hospital in New York City. Dr. Adams is a recognized leader in the field of heart valve surgery and mitral valve reconstruction. As director of Mount Sinai Mitral Valve Repair Center, he has set national benchmarks with >99% degenerative mitral valve repair rates, while running one of the largest valve repair programs in the United States. Dr. Adams is the co-inventor of 2 mitral valve annuloplasty repair rings – the Carpentier-McCarthy-Adams IMR ETlogix Ring and the Carpentier-Edwards Physio II Annuloplasty Ring, and is a senior consultant with royalty agreements with Edwards Lifesciences. He is also the inventor of the Tri-Ad Adams Tricuspid Annuloplasty ring with a royalty agreement with Medtronic. He is a co-author with Professor Alain Carpentier of the benchmark textbook in mitral valve surgery Carpentier's Reconstructive Valve Surgery. He is also the National Co-Principal Investigator of the FDA pivotal trial of the Medtronic-CoreValve transcatheter aortic valve replacement device.

The pericardial heart valve was invented by Marian Ionescu, a British surgeon working at the General Infirmary in Leeds, England. He created this artificial bioprosthetic heart valve as a three-cusp structure made of chemically treated bovine pericardium attached to a Dacron cloth-covered titanium frame.

A valvulotomy, valvotomy, valvuloplasty, or valvoplasty is a procedure used in heart valve surgery that consists of making one or more incisions at the edges of the commissure formed between the two, or three tricuspid valve leaflets. This relieves the constriction of valvular stenosis.

Heart valve repair is a cardiac surgery procedure, carried out to repair one or more faulty heart valves. In some valvular heart diseases repair where possible is preferable to valve replacement. A mechanical heart valve is a replacement valve that is not itself subject to repair.

<span class="mw-page-title-main">Hybrid cardiac surgery</span>

A hybrid cardiac surgical procedure in a narrow sense is defined as a procedure that combines a conventional, more invasive surgical part with an interventional part, using some sort of catheter-based procedure guided by fluoroscopy imaging in a hybrid operating room (OR) without interruption. The hybrid technique has a reduced risk of surgical complications and has shown decreased recovery time. It can be used to treat numerous heart diseases and conditions and with the increasing complexity of each case, the hybrid surgical technique is becoming more common.

Gilles Dreyfus is a French cardiac surgeon.

<span class="mw-page-title-main">MitraClip</span>

MitraClip is a medical device used to treat mitral valve regurgitation for individuals who should not have open-heart surgery. It is implanted via a tri-axial transcatheter technique and involves suturing together the anterior and posterior mitral valve leaflets.

<span class="mw-page-title-main">Christoph Huber</span> Swiss cardiac surgeon

Christoph Huber MD, FMH, FECTS is a Swiss cardiac surgeon who is a professor and the head of the Division of Cardiac and Vascular Surgery at the University Hospital Geneva, Switzerland.

Transcatheter pulmonary valve replacement (TPVR), also known as percutaneous pulmonary valve implantation (PPVI), is the replacement of the pulmonary valve via catheterization through a vein. It is a significantly less invasive procedure in comparison to open heart surgery and is commonly used to treat conditions such as pulmonary atresia.

<span class="mw-page-title-main">Samin Sharma</span> American interventional cardiologist

Samin K. Sharma is an American philanthropist of Indian descent and an interventional cardiologist who co-founded the Eternal Heart Care Centre and Research Institute in Jaipur (EHCC). Sharma has served on New York State’s Cardiac Advisory Board since 2004. As of 2021, he is Senior Vice-President, Operations & Quality at The Mount Sinai Hospital in New York and runs the Dr. Samin K. Sharma Family Foundation Cardiac Catheterization Laboratory. As of 2018, he is Chairman Board of Trustees, Association of Indians in America (AIA). As of 2022, he has been an investigator on 86 grants and multi-center trials and authored 486 peer-reviewed articles that have been cited 21,734 times.

Joseph E. Bavaria, M.D., FACS, FRCS (Edin) ad hom, is an American cardiothoracic surgeon a professor of surgery at the University of Pennsylvania and Director of its Thoracic Aortic Surgery Program. Bavaria is known as a leading figure in clinical trials for catheter-based aortic valve replacement (TAVR), thoracic aortic surgery, and aortic endograft procedures (TEVAR). He wrote more than 600 research papers and founded the Penn Aortic Center. Bavaria served as the 52nd president of the Society of Thoracic Surgeons (STS) from 2016 to 2017, the 3rd President of the Thoracic Surgery Foundation (TSF) (2019-2022), the Chairman of The Society of Thoracic Surgeons/ACC TVT Registry Steering Committee (2017-2020) and an International Councilor of the European Association for Cardio-Thoracic Surgery (EACTS) (2021-2024) Bavaria has performed more than 9,000 surgeries throughout his career as of 2019.

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. ↑ https://www.bloomberg.com/news/articles/2024-06-03/bd-to-buy-edwards-life-s-critical-care-unit-for-4-2-billion
  26. ↑ "#15 Edwards Lifesciences". Forbes . May 15, 2019.
  27. ↑ "Declining echo exams during COVID-19 may have staggering consequences". August 28, 2020.
  28. 1 2 "Edwards expands its Every Heartbeat Matters initiative". Cardiovascular News. February 21, 2020.
  29. ↑ "Edwards Lifesciences' Every Heartbeat Matters is Expanding". MPO. February 21, 2020.
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