Health

FDA clears first U.S. catheter device built to seal leaks around replacement heart valves

United States • October 28, 2026 • By Press Pass USA

Editorial illustration: a cardiologist in a catheterization lab holding a small catheter-delivered heart device, monitors softly blurred behind

Editorial illustration — Press Pass USA

The U.S. Food and Drug Administration has approved the first catheter-delivered device designed specifically to close leaks around replacement heart valves, Abbott announced Wednesday, giving some patients an alternative to another open-heart operation.

The device, the Amplatzer Paraclose PVL Occluder, treats paravalvular leak — blood flowing backward through a gap between a patient's own heart tissue and a surgically implanted replacement valve. The gap can remain after surgery or develop years later. According to Abbott, such leaks occur in 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements, and can cause heart-failure symptoms including shortness of breath, fatigue and leg swelling, or damage red blood cells and cause severe anemia.

The occluder is delivered through a catheter inserted into an artery or vein in the leg and positioned inside the leak to close it. Its elliptical shape is designed to seal a wide range of leak shapes and sizes. Abbott says it is the first and only transcatheter device approved in the U.S. specifically for this use; physicians previously had no approved alternative to repeat open-heart surgery for these patients. The device has been available in Europe since 2020, where it is known as the Amplatzer Valvular Plug III.

FDA approval was supported by the PARADIGM study, a prospective, multicenter, single-arm study of 200 patients who had undergone aortic or mitral valve replacement surgery. The approval covers clinically significant paravalvular leaks associated with surgical aortic or mitral valve prostheses — not every leak or every type of valve.

Sources: Abbott announcement, reported by Cardiovascular Business and Diagnostic and Interventional Cardiology (Oct 28, 2026); Securities.io (Oct 28, 2026).