PVL Occluder Receives FDA Clearance

Oct. 28, 2026 — Abbott has received U.S. Food and Drug Administration (FDA) approval for the Amplatzer Paraclose PVL Occluder. It is the 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.ⁱⁱ 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.  

“The U.S. approval of the Amplatzer Paraclose PVL Occluder addresses a significant treatment gap for people suffering from a paravalvular leak,” said  Amar Krishnaswarmy, M.D., section head of Invasive & Interventional Cardiology in the Robert and Suzanne Tomisch Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at the Cleveland Clinic. “Its unique elliptical shape is specifically designed to effectively close a wide range of PVL shapes and sizes that allows many patients to avoid another cardiac surgery.” 

The Unique Challenges of PVL Closure  

Delivered through an artery or vein in the leg, the Amplatzer Paraclose device has an oblong shape and unique design features to enable effective closure across diverse PVL anatomies.  

Study Data Supports FDA Approval

FDA approval for the Amplatzer Paraclose PVL Occluder was supported by positive clinical data from the PARADIGM study, a prospective, multicenter, single arm study that includes 200 patients, demonstrating that Amplatzer Paraclose provides an effective, minimally invasive alternative to open-heart reoperation. 

“Offering this purpose-built device fills a critical unmet need as physicians treating PVL in the U.S. previously didn’t have an approved alternative to repeat open-heart surgery,” said Sandra Lesenfants, senior vice president of Abbott's structural heart business. “The Amplatzer Paraclose PVL Occluder builds upon Abbott’s minimally invasive portfolio of structural heart devices that allows people with cardiovascular conditions to be effectively treated without the risk of surgical complications.”