A tiny plug, threaded in through the leg, can now spare heart patients a second open-heart surgery

For people whose replacement heart valve leaks — blood slipping back through a small gap beside the valve — the only approved fix in the USA used to be another open-heart operation. The Food and Drug Administration has now approved Abbott's Amplatzer Paraclose PVL Occluder, the first device of its kind: an oblong plug delivered through a catheter in an artery or vein in the leg and positioned inside the leak to seal it. The approval rests on PARADIGM, a study of 200 patients who had aortic or mitral valve replacements. 'Offering this purpose-built device fills a critical unmet need,' said Sandra Lesenfants of Abbott's structural heart business. Cleveland Clinic cardiologist Amar Krishnaswarmy noted its elliptical shape can close a wide range of leak shapes and sizes. The device has been used in Europe since 2020 under a different name.

SDG 3 · Good health and well-being — Mechanism: tech innovation