FDA Approves Edwards EVOQUE Tricuspid Valve Replacement System

February 29, 2024 // Southern Medical Association

The US Food & Drug Administration (FDA) recently approved the Edwards EVOQUE Tricuspid Valve Replacement System – P230013.

According to the FDA's overview, the "EVOQUE valve is intended to treat patients with severely leaky tricuspid valve (tricuspid regurgitation) often caused by an enlarged heart or damaged native valve flaps (called leaflets)."

Additionally, the "EVOQUE valve could reduce the amount of blood that moves in the wrong direction through the tricuspid valve. As a result, the patient may have: improved quality of life, relief of symptoms such as tiredness or fatigue, [and] improved ability to exercise".

Click here to view the FDA's informational overview of this product.

Posted in: 2024
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