Second Transcatheter Therapy for the Treatment of Tricuspid Valve Regurgitation Approved by the FDA

The Alliance for Aging Research and Heart Valve Voice US applaud the U.S. Food & Drug Administration’s (FDA) approval of TriClip, the second minimally invasive transcatheter device to repair leaky tricuspid heart valves, known as tricuspid valve regurgitation (TR). According to the FDA, the TriClip is indicated for “improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.” This approval follows the February 13, 2024 recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks.

“We thank the FDA for considering the patient perspective in determining approval for new heart valve technologies. Embracing innovation in heart valve care not only benefits individual patients but also contributes to advancing cardiovascular healthcare as a whole,” said Lindsay Videnieks, Executive Director for Heart Valve Voice US, and a speaker at the FDA’s February 13 Advisory Committee public comment session.”

Heart Valve Voice US and the Alliance co-convene the Heart Valve Disease Policy Task Force, which submitted a February 7 sign-on letter  urging the FDA and its Advisory Committee to consider the perspectives of people living with tricuspid heart valve disease and those who care for them.

“This second FDA approval is great news because it means that clinicians and patients will have a choice of minimally invasive treatment options for symptomatic severe TR,” said Alliance President & CEO Sue Peschin, MHS. “These transcatheter technologies offer older, sicker patients a chance at a better quality of life.”

Tricuspid regurgitation, or tricuspid valve regurgitation, is a type of heart valve disease that occurs when the valve’s flaps (cusps or leaflets) do not close properly, and it is estimated to impact more than 1.5 million people in the United States. Patients with severe tricuspid regurgitation frequently have co-morbid congestive heart failure. These combined conditions cause debilitating symptoms—such as severe fatigue and shortness of breath, an enlarged liver, kidney failure and fluid accumulation in the abdomen, legs, ankles, or feet—that can significantly impact daily function and quality of life. When left untreated, TR can lead to atrial fibrillation, heart failure, and ultimately, death.

The next step for these technologies is Medicare coverage, to be determined by the Centers for Medicare and Medicaid Services (CMS). The Heart Valve Disease Policy Task Force calls on CMS to provide equitable access to transcatheter tricuspid therapies for all eligible Medicare beneficiaries.

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The Alliance for Aging Research is the leading nonprofit organization dedicated to changing the narrative to achieve healthy aging and equitable access to care. The Alliance strives for a culture that embraces healthy aging as a greater good and values science and investments to advance dignity, independence, and equity. Each year on February 22, the Alliance leads more than 125 partner organizations in raising awareness of the risks, symptoms, and treatments of valve disease on Heart Valve Disease Awareness Day. Learn more about heart health and this important day at ValveDiseaseDay.org.

Heart Valve Voice US is an organization dedicated to providing patients with a united voice to improve health for people living with heart valve disease by advocating for early detection, meaningful support, and timely access to appropriate treatment for all people affected by heart valve disease. Heart Valve Voice US works with people living with heart valve disease, their caregivers, clinicians and other experts, and other patient service and advocacy organizations to identify barriers to improving health for people living with valve disease and advocates for change to enhance health.