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Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment

The Evoque valve will serve patients with few treatment options, wrote RBC analyst Shagun Singh.

Edwards Lifesciences received approval from the Food and Drug Administration for its Evoque tricuspid valve replacement system, making it the first company to bring a transcatheter treatment for tricuspid regurgitation to the U.S.

Tricuspid regurgitation is a condition where the valve between the two right heart chambers doesn’t close properly, allowing blood to leak backward. Edwards’ Evoque device is inserted through a minimally invasive surgery and is designed to replace the tricuspid valve.

Competitor Abbott has submitted a device for FDA approval called TriClip, which clips together a portion of the leaflets of the tricuspid valve to prevent blood from leaking back. The FDA plans to hold an advisory panel on Feb. 13 to discuss the device.

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