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Edwards Lifesciences | Reducing Deaths, Strokes and Rehospitalisation Rates | WELL

Representing the key sub-theme of Biological Engineering in our HAN-GINS Indxx Healthcare Innovation UCITS ETF, Edwards Lifesciences is an American medical equipment company specialising in artificial heart valves and hemodynamic monitoring. It is mostly known for a transcatheter aortic heart valve made of bovine tissue within a collapsible stainless-steel stent, deployed via catheter [1]. 

The focus of the business is on these 3 areas:

  • Critical care technologies 
  • Surgical valve technologies
  • Transcatheter heart valves

The Irvine, California based company is a leading manufacturer of heart valve systems and repair products used to replace or repair a patient's diseased or defective heart valve.

It also develops hemodynamic monitoring systems that are used to measure a patient's cardiovascular function in the hospital setting.

The Edwards SAPIEN 3 Transcatheter Heart Valve (often referred to as SAPIEN 3 THV) consists of a catheter-based artificial heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support [2].

In March 2019, Edwards Lifesciences Corp. shares soared the most in two years after studies showed that patients with damaged aortic valves fared better if they were treated with the company’s easier-to-implant replacement device rather than the gold-standard surgery that involves cracking open the chest. Its Sapien 3 valve cut death, stroke and hospitalisation rates dramatically.  These results will most likely lead to expanded use of the devices globally [3].

For many decades, surgeons have repaired leaky aortic valves with one of medicine’s most dramatic procedures, splitting the sternum and stopping the heart to sew a new valve in place while the patient is kept alive by machines. The new valves are inserted through an incision in the leg, threaded up to the heart, and then fixed in place far less invasively.

The new valves are already approved for use in about 20% of patients who are too sick to withstand open-heart surgery or may have complications from the operation. The latest company-sponsored findings, suggest they should be used in almost all patients [4].

The heart procedures make up 61% of Edwards’s revenues, and expanding use of the devices is a key part of Wall Street’s optimistic view about the company. In the U.S., there are about 90,000 diagnosed, low-risk patients, according to Jason McGorman, an analyst with Bloomberg Intelligence.  He stated this expanded use amounted to a $2.5 billion opportunity [5]. 

Patients given Edwards’s Sapien 3 valve were almost half as likely to die, suffer a stroke or need to be hospitalised again within the first year of treatment as those who underwent a traditional operation [6]. 

The default until now has been surgical valves, unless you are in a very high-risk group.  Going forward surgery will be only for cases where TAVR (transcatheter aortic valve replacement) won’t work. This is a true game-changer.

As the valves are used in younger and healthier patients, it’s not clear how they’ll hold up over the long term compared with surgically implanted valves that have a much longer track record.

This TAVR procedure enables the placement of a collapsible heart valve into the body via a tube-based delivery system (catheter) that can be inserted through multiple access routes, including either an incision in the leg (transfemoral), or in between the ribs and to be threaded up to the heart (transapical), or through the front of the chest and then through a small hole in the aorta (transaortic). The valve is designed to replace a patient’s diseased native aortic valve without traditional open-heart surgery and while the heart continues to beat – avoiding the need to stop the patient’s heart and connect them to a heart-lung machine that temporarily takes over the function of the heart and the patient’s breathing during surgery (cardiopulmonary bypass).

Edwards continues as a leader in the field of tissue replacement heart valves and repair products and advanced hemodynamic monitoring, which have helped treat and manage more than 2 million patients worldwide.  Annually, more than 300,000 valve replacements are performed worldwide through open-heart surgery, utilising either bioprosthetic tissue valves or mechanical valves [7].

Find out more about the HAN-GINS Indxx Healthcare Innovation UCITS ETF (WELL).

As of 12th June 2019 , the HAN-GINS Indxx Healthcare Innovation UCITS ETF (WELL) held 5.61% in Edwards Lifesciences Corp.

[1] https://www.edwards.com/gb/ | 2019.

[2]https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm561731.htm | October, 2017.

[3] https://www.evaluate.com/vantage/articles/news/trial-results/acc-2019-low-risk-patients-being-denied-transcatheter-aortic | March, 2019

[4] https://www.bloomberg.com/news/articles/2019-03-16/heart-replacement-valves-from-edwards-and-medtronic-beat-surgery | March 2019

[5] https://www.bloomberg.com/news/articles/2019-03-16/heart-replacement-valves-from-edwards-and-medtronic-beat-surgery | March, 2019.

[6] https://www.bloomberg.com/news/articles/2019-03-16/heart-replacement-valves-from-edwards-and-medtronic-beat-surgery |March 2019.

[7] https://www.edwards.com/gb/aboutus/OurHistory| 2019. 

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