Edwards Lifesciences, Medtronic heart valves win U.S. approval for expanded use in TAVR

Heart valve systems from Edwards Lifesciences Corp and Medtronic Plc have been approved for use in a condition that restricts blood flow from the heart in patients at low risk of death linked to open-heart surgeries, the U.S. FDA said on Friday.

The Food and Drug Administration approved two of Edwards' transcatheter heart valve systems called Sapien 3 And Sapien 3 Ultra as well as Medtronic's Evolut Transcatheter Aortic Valve Replacement (TAVR)system.

The heart valves from the two companies were already approved for patients at intermediate or high risk of death or major complications during open-heart surgeries to replace damaged valves in patients with aortic stenosis.

The condition occurs when the heart's aortic valve narrows, restricting blood flow from the organ into the main artery carrying blood to the rest of the body.

Edwards, which currently dominates the U.S. market for TAVR, is more levered to the market than Medtronic, but both device makers should benefit from accelerating utilization trends with the new approval, Cowen & Co analyst Joshua Jennings said.

The worldwide TAVR market is expected to maintain a mid-to-high-teens growth trajectory over the remainder of 2019, Jennings said.

In TAVR, a catheter is used to put a replacement heart valve into place through an artery, sparing patients chest-cracking surgery.

Patients take much shorter recovery time with minimally invasive TAVR procedures, Dr. Mathew Williams, director of the Heart Valve Center at NYU Langone Health, said. "I've had patients go to work the day after the procedure."

The latest approval expands the number of patients who can be treated with this less invasive procedure for aortic valve replacement, the health agency said.

About 165,000 low-risk patients suffer from severe aortic stenosis each year in the United States, Western Europe and Japan, according to Medtronic.

The U.S. low-risk population will represent more than 40% of the total treatable U.S. TAVR population, Medtronic said.

The company awaits marketing approval for low-risk patients in the European Union.

Reporting by Manojna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila and Maju Samuel

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