October 28, 2026- Abbott, the global healthcare leader, 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. 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. These blood leaks occur in 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements. PVL can lead to symptoms associated with heart failure, including shortness of breath, fatigue and swelling of the legs and feet. It can also result in hemolysis, a condition where red blood cells are damaged, causing severe anemia. Implanted through a catheter that is inserted through an artery or vein in the leg, the Amplatzer Paraclose device offers patients a minimally invasive treatment option to address PVL without requiring another surgery.