Edwards Lifesciences, Medtronic heart valves win FDA approval for expanded use

(Reuters) – 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 FDA said on Friday.

Shares of Edwards Lifesciences rose 2.2% to $219.9 in afternoon trading, while Medtronic’s stock gained 1% to $102.9.

The heart valves were previously approved for patients at intermediate or higher 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.

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.

The agency on Friday approved two of Edwards’ transcatheter heart valve systems called Sapien 3 And Sapien 3 Ultra, while backing Medtronic’s Evolut Transcatheter Aortic Valve Replacement system.

Reporting by Manojna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila

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source: reuters.com