Edwards’ EVOQUE Valve Replacement System Receives FDA Approval

FDA Approved

In a groundbreaking development, Edwards Lifesciences Corporation has announced that its EVOQUE tricuspid valve replacement system has become the first transcatheter therapy to be granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of tricuspid regurgitation (TR). This significant milestone marks a pivotal moment in the field of structural heart disease, offering hope to countless patients suffering from severe TR.

The EVOQUE system, designed to improve health status in patients with symptomatic severe TR despite optimal medical therapy, represents a leap forward in transcatheter treatment options. Comprised of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from bovine pericardial tissue, the EVOQUE valve promises enhanced patient outcomes and improved quality of life.

Dr. Susheel Kodali, director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and principal investigator of the TRISCEND II Study, hailed the EVOQUE system as a game-changer for patients with TR. The successful results of the TRISCEND II pivotal trial, presented at TCT 2023, demonstrated the system’s superiority to optimal medical therapy alone, with significant reductions in tricuspid regurgitation and sustained improvements in quality of life.

As we celebrate this milestone in transcatheter therapy, it’s important to recognize the impact of heart disease on women. WomenHeart, the first and only national patient-centered organization dedicated to serving women with heart disease, continues to advocate for equitable access to life-saving treatments and support services. With heart disease remaining the leading cause of death for women, advancements like the EVOQUE system offer renewed hope and promise for female patients nationwide.

Edwards Lifesciences’ commitment to patient-focused innovation aligns with WomenHeart’s mission to improve the lives of women living with or at risk for heart disease. Together, we can continue to bridge gaps in heart care and empower women to lead heart-healthy lives.

For more information on Edwards’ EVOQUE valve replacement system and WomenHeart’s advocacy efforts, visit their respective websites.

*Disclaimer: This blog post includes forward-looking statements. For more information, please refer to the original press release by Edwards Lifesciences Corporation.*