FDA Approves First Transcatheter Device for Paravalvular Leak Closure

Paravalvular leak is a backflow of blood around a surgical heart valve that can follow valve replacement, causing heart failure symptoms or hemolysis. These leaks occur in 7%–17% of mitral valve replacements and 5%–10% of aortic valve replacements. A new device now offers a transcatheter option specifically designed to close these leaks without additional surgery.

The Amplatzer Paraclose PVL Occluder is a minimally invasive implant for paravalvular leak (PVL) closure around surgical replacement heart valves. It is designed to address the backflow that can occur when a small gap remains or develops between native tissue and the implanted valve. The system offers patients an alternative to repeat open‑heart surgery.

Implanted through a catheter inserted via an artery or vein in the leg, the device is positioned within the PVL to achieve closure. It features an oblong, elliptical shape with design elements intended to enable effective closure across diverse PVL anatomies. This transcatheter approach aims to reduce the need for another surgical procedure by sealing the leak percutaneously.

On October 28, 2026, Abbott received U.S. Food and Drug Administration (FDA) approval for the Amplatzer Paraclose PVL Occluder. The approval makes it the first and only transcatheter device in the United States specifically designed to treat PVL. The device is intended to close leaks that occur around surgical heart valves.

Regulatory authorization was supported by positive clinical data from the PARADIGM study, a prospective, multicenter, single‑arm investigation that includes 200 patients. Study findings reinforced the device’s safety and effectiveness for PVL closure. The study also demonstrated that the system provides an effective, minimally invasive alternative to open‑heart reoperation.

Outside the United States, the device is known as the Amplatzer Valvular Plug III and has been approved to treat PVL in Europe since 2020. Important safety information is available for U.S. use of the device. While Abbott’s broader Amplatzer portfolio includes occluders for congenital heart defects and stroke risk reduction, Paraclose is designed specifically for PVL.

“The U.S. approval of the Amplatzer Paraclose PVL Occluder addresses a significant treatment gap for people suffering from a paravalvular leak. 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,” 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.

“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. 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,” stated Sandra Lesenfants, senior vice president of Abbott's structural heart business.