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FDA Approves Abbott’s Paraclose Heart-Valve Leak Device

lite News Desk 1 min read

Abbott’s Amplatzer Paraclose PVL Occluder has received U.S. Food and Drug Administration approval for treating leaks around surgically replaced heart valves, according to the company’s October 28, 2026, announcement. Abbott said it is the first device approved in the United States specifically for catheter-based treatment of this condition, known as paravalvular leak.

According to Abbott, a paravalvular leak occurs when blood passes between a replacement valve and the surrounding natural tissue. That opening can persist following the valve-replacement operation or form afterward. Paraclose is designed to close the opening using a catheter-based procedure rather than another open-heart operation, the company said.

The company’s description places the device at the leak using a catheter introduced through a leg artery or vein. Its oblong shape is designed to accommodate openings with different dimensions and shapes, according to Abbott.

For the approval evidence, Abbott identified PARADIGM, a study with 200 participants. The study was prospective, involved multiple centers and used a single-arm design. Cardiovascular Business separately reported that the FDA examined PARADIGM data involving patients with replacement aortic or mitral valves. Neither account supplied numerical outcome results.

The U.S. approval follows earlier use of other occluders for catheter-based leak closure. In a review published in 2019, Cardiac Interventions Today described clinicians performing that procedure with other devices, while noting that none then had FDA approval specifically for transcatheter treatment of paravalvular leaks. Cardiovascular Business also reported Paraclose’s approval and its status as the first U.S.-approved device designed for that purpose.

Outside the United States, Abbott said, the product carries the name Amplatzer Valvular Plug III. According to the company, European approval for treating paravalvular leaks dates to 2020.

* This article is based on publicly available information at the time of writing.

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