Edwards' Transcatheter Tricuspid Valve Replacement Gets CE Mark

It's comprised of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets.

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Edwards Lifesciences

Edwards Lifesciences announced the company's EVOQUE tricuspid valve replacement system received CE Mark for the transcatheter treatment of eligible patients with tricuspid regurgitation (TR). The company said the EVOQUE system is the world's first transcatheter valve replacement therapy to receive regulatory approval to treat TR. 

The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the same bovine pericardial tissue as the company's market-leading heart valves. The EVOQUE valve will be available in three sizes, all delivered through a low-profile transfemoral 28F system.

One-year results on patients treated in the single-arm, prospective, global, multi-center TRISCEND study of the EVOQUE system were presented at PCR London Valves 2022 and demonstrated favorable safety and effectiveness outcomes and significant quality-of-life improvements. Key findings included high survival (90.1%) and high freedom from heart failure hospitalization (88.4%); significant and sustained TR reduction to mild or trace TR (97.6%); and significantly improved functional and quality-of-life outcomes (93% of patients in NYHA Class I or II compared to 26% at baseline and a 26-point increase in KCCQ score over baseline).

Patients with tricuspid valve disease suffer greatly with symptoms ranging from debilitating to life-threatening with few effective options for relief. Other transcatheter therapies in Edwards' tricuspid portfolio with CE Mark approval include the PASCAL Precision transcatheter repair system and the Cardioband annular reduction system. The company does not yet have any transcatheter therapies approved for treatment of the tricuspid valve in the United States.

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