Abbott has secured U.S. FDA approval for the Amplatzer Paraclose PVL Occluder, the first minimally invasive device in the nation designed to seal paravalvular leaks around surgical replacement heart valves. Such leaks impact up to 17% of mitral and 10% of aortic valve replacements, causing shortness of breath and red blood cell damage. Supported by 200-patient PARADIGM trial data, the catheter-delivered device enables patients to avoid repeat open-heart surgeries.
Amplatzer Paraclose FDA approval
- ▪Abbott received U.S. Food and Drug Administration approval on October 28, 2026 for the Amplatzer Paraclose PVL Occluder, a transcatheter device designed to close gaps between heart tissue and surgical replacement valves.
- ▪The Amplatzer Paraclose PVL Occluder is implanted via a catheter delivered through a leg artery or vein, and has been approved in Europe under the name Amplatzer Valvular Plug III since 2020.
- ▪The Amplatzer Paraclose PVL Occluder is the first minimally invasive device approved in the United States to treat paravalvular leaks around surgical heart valves, offering an alternative to repeat open-heart surgery.
Paravalvular leak prevalence
- ▪According to Abbott, paravalvular leaks occur in 7% to 17% of mitral valve replacements after surgical heart valve implantation.
- ▪According to Abbott, paravalvular leaks occur in 5% to 10% of aortic valve replacements following surgical valve replacement.
Paravalvular leak symptoms
- ▪Paravalvular leaks can lead to medical complications including shortness of breath, leg and foot swelling, and damage to red blood cells.
- ▪Sandra Lesenfants, senior vice president of Abbott's structural heart business, stated that the Amplatzer Paraclose device addresses a critical unmet need that helps patients avoid the risks of secondary open-heart surgery.
PARADIGM trial clinical data
- ▪Abbott stated it will present 30-day clinical results from the 200-patient PARADIGM trial at the Transcatheter Cardiovascular Therapeutics conference in San Diego.
- ▪FDA approval of the Amplatzer Paraclose PVL Occluder was supported by clinical data from the PARADIGM trial, a prospective, multicenter, single-arm study of 200 patients.
Abbott Amplatzer device portfolio
- ▪Abbott manufactures the Amulet implant to reduce stroke risk in patients with atrial fibrillation, with a next-generation version receiving European CE mark approval in August 2026 while remaining under U.S. FDA review.
- ▪Abbott's structural heart portfolio includes the Amplatzer Piccolo Occluder for closing congenital heart defects and the Talisman PFO Occluder for stroke risk reduction.
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