Research · October 29, 2026

Abbott's Amplatzer Paraclose: The First U.S. Device to Close Valve Leaks Without Another Surgery

Abbott won U.S. FDA approval for the Amplatzer Paraclose PVL Occluder, the first transcatheter device purpose-built to close leaks around replacement heart valves — a minimally invasive alternative to repeat open-heart surgery.

On October 28, 2026, Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for the Amplatzer™ Paraclose PVL Occluder, the first and only transcatheter device approved in the U.S. specifically designed to treat paravalvular leak (PVL), a backflow of blood around a surgical heart valve. For patients living with a leak after valve replacement, the approval adds a minimally invasive option where the previous alternative was another open-heart surgery.

What a paravalvular leak is. When a diseased or damaged heart valve cannot be repaired, it may be replaced with a mechanical or tissue valve in an open-heart surgical procedure. After that surgery, a small gap can remain or develop between the native heart tissue and the replacement valve, and blood leaking through that gap is known as a paravalvular leak. Abbott cites a 2014 study in The Journal of Thoracic and Cardiovascular Surgery for the frequency: leaks occur in 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements. A leak can lead to symptoms associated with heart failure, including shortness of breath, fatigue and swelling of the legs and feet, and it can also result in hemolysis, a condition in which red blood cells are damaged, causing severe anemia. The Amplatzer Paraclose device is implanted through a catheter inserted through an artery or vein in the leg and positioned within the leak to close it — no repeat chest-opening operation.

The evidence behind the approval. Abbott states that FDA approval was supported by positive clinical data from the PARADIGM study, a prospective, multicenter, single-arm study that includes 200 patients, demonstrating that the device provides an effective, minimally invasive alternative to open-heart reoperation. Amar Krishnaswarmy, M.D., of Cleveland Clinic, said the device's elliptical shape is specifically designed to effectively close a wide range of PVL shapes and sizes, allowing many patients to avoid another cardiac surgery. Sandra Lesenfants, senior vice president of Abbott's structural heart business, said physicians treating PVL in the U.S. previously did not have an approved alternative to repeat open-heart surgery, and that offering this purpose-built device fills a critical unmet need. The device itself has an oblong shape with design features intended to enable effective closure across diverse PVL anatomies, and it builds on Abbott's broader minimally invasive structural heart portfolio.

What this is — and what it is not. This is a U.S. marketing approval for a device, not a trial authorization and not a drug approval: physicians in the U.S. can now use a purpose-built device for PVL closure instead of improvising with off-label devices or sending patients back to surgery. Outside the U.S., the same device is known as the Amplatzer Valvular Plug III, which has been approved to treat PVL in Europe since 2020 — so the U.S. approval closes a geographic gap rather than introducing a first-in-the-world implant. The announcement discloses no price, no sales forecast, no launch date, and no implant volume target, and this article claims none of those. The "first and only" characterization describes the U.S. approval status as Abbott presents it, and the characterization of PARADIGM as demonstrating an effective alternative is Abbott's description of its study data, not an independent verification by this article.

For BlitzLab readers, the through-line is the quiet end of structural heart innovation: not a new platform or a new disease category, but a purpose-built tool that removes one repeat-surgery risk for a defined, previously unserved patient subset. Much of medical device progress arrives this way — a gap that every clinician in the field knows, closed by a device shaped for exactly that anatomy. Abbott (NYSE: ABT) does not currently carry a BlitzLab score, and this article is not a rescore — it is a regulatory data point about how a large device maker extends a minimally invasive portfolio one indication at a time.

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