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Alliance Celebrates the First-Ever, FDA approval of a Transcatheter Therapy for the Treatment of Tricuspid Regurgitation

Published February 5, 2024

Older white hand holding a red paper heart.

The Alliance for Aging Research celebrates the first-ever, U.S. Food and Drug Administration (FDA) approval of a transcatheter therapy for the treatment of tricuspid regurgitation (TR). The EVOQUE tricuspid valve replacement system was approved through the FDA’s Breakthrough Devices Program, and is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.

“We commend the FDA’s deliberative review under its congressionally authorized Breakthrough Devices Program, which is intended to provide patients and health care providers with timely access to more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions,” said Alliance President & CEO Sue Peschin, MHS. “We also recognize that this landmark approval comes during American Heart Month, when the Alliance works to raise awareness of heart-related illness and diseases, with a special focus on Heart Valve Disease Awareness Day on February 22.”

Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing.

Despite its prevalence and clinical significance, TR is often underdiagnosed and undertreated, leaving many patients with limited therapeutic options. Patients with severe tricuspid regurgitation frequently have symptoms such as severe fatigue and shortness of breath, an enlarged liver, kidney failure and fluid accumulation in the abdomen, legs, ankles, or feet. These often uncomfortable and debilitating symptoms can significantly impact daily function and quality of life.

This approval marks the first non-surgical, minimally invasive treatment for people with severe TR. The FDA’s approval of the EVOQUE tricuspid valve replacement system provides healthcare providers with a much-needed option to improve outcomes and enhance the quality of life for patients living with severe TR. 

“Now, the next move is in the hands of the Centers for Medicare and Medicaid Services (CMS) and we will be watching closely,” says Peschin. “The Alliance calls on CMS to provide equitable access to transcatheter tricuspid therapies for all eligible Medicare beneficiaries.”

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