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Abbott stories

Oct 29, 2026

Abbott wins FDA approval for Amplatzer Paraclose device to treat heart valve leaks

Abbott received FDA approval for its Amplatzer Paraclose PVL Occluder, the first transcatheter device designed to close paravalvular leaks around surgical replacement heart valves without requiring additional open-heart surgery.

Oct 29, 2026·1 source

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Top claims

▪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.
▪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.
▪Abbott's structural heart portfolio includes the Amplatzer Piccolo Occluder for closing congenital heart defects and the Talisman PFO Occluder for stroke risk reduction.

Topics

FDA regulatory approval Healthcare technology Medical implants Cardiovascular diseases Healthcare industry Medical innovation Biomedical engineering

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