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Edwards EVOQUE Tricuspid Valve Replacement System – P230013

 

EVOQUE Tricuspid Valve Replacement System is an artificial heart valve

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Edwards EVOQUE Tricuspid Valve Replacement System
PMA Applicant: Edwards Lifesciences LLC
Address: One Edwards Way, Irvine, CA 92614
Approval Date: February 01, 2024
Approval Letter: Approval Order


What is it?

The Edwards EVOQUE Tricuspid Valve Replacement System mainly includes an artificial tricuspid valve (called the EVOQUE valve) and a delivery catheter. The EVOQUE valve is made of cow tissue attached to a self-expanding metal (nickel-titanium) frame for support. It can be used to replace the tricuspid valve of the heart without open-heart surgery. The tricuspid valve prevents backflow of blood into the right atrium (upper right chamber of the heart) from the right ventricle (lower right chamber of the heart).

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