FDA Approves First Nonsurgical Medical Device to Treat Patients With Congenital Heart Disease

The U.S. Food and Drug Administration (FDA) on March 26 approved the Harmony Transcatheter Pulmonary Valve (TPV) as the world's first nonsurgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT). The device is designed for patients who have severe pulmonary valve regurgitation, and is intended to both delay and reduce the number of required lifetime open-heart surgeries by improving blood flow to the lungs.

The FDA approval was based on safety and efficacy data demonstrated through a prospective, non-randomized, multi-center clinical study including 70 patients evaluated over five years. The primary safety endpoint, avoiding procedure- or device-related death, was achieved by 100% of patients at 30 days. Among patients with evaluable echocardiography data, 89.2% achieved the primary effectiveness endpoints of not requiring additional surgical or interventional procedures related to the device and having acceptable heart blood flow function at six months. Adverse events observed during the study included: irregular or abnormal heart rhythms (23.9%), leakage around the valve (8.5%), minor bleeding (7.0%), narrowing of the pulmonary valve (4.2%), and movement of the implant (4.2%).

The device was awarded a "breakthrough device" designation by the agency. Read the full FDA press release here.

Keywords: ACC Advocacy, Pulmonary Valve Insufficiency, Pulmonary Valve, United States Food and Drug Administration, Heart Defects, Congenital, Cardiac Surgical Procedures


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