Abbott Receives FDA Approval

Abbott Receives FDA Approval for First and Only Device in the U.S. to Treat Leaks After Heart Valve Replacement Without Additional Surgery

• Amplatzer™ Paraclose PVL Occluder is a minimally invasive device for paravalvular leak (PVL) closure that offers patients an alternative to repeat open-heart surgery
• PVL is a backflow of blood that can commonly occur around a replacement heart valve

ABBOTT PARK, Ill., Oct. 28, 2026 — Abbott, the global healthcare leader, announced today 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. that is specifically designed to treat paravalvular leak (PVL), a backflow of blood around a surgical heart valve.

When diseased or damaged heart valves can’t be repaired, they may be replaced with either mechanical or tissue valves in an open-heart surgical procedure. Following heart surgery, sometimes a small gap between the native heart tissue and replacement valve can remain or develop over time and lead to PVL.

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