Abbott Amplatzer Paraclose PVL Occluder Wins FDA Approval

Abbott announced on October 28, 2026, that it has received U.S. Food and Drug Administration approval for the Amplatzer Paraclose PVL Occluder, a transcatheter device designed to treat paravalvular leak (PVL), a backflow of blood around a surgical heart valve. In its announcement, Abbott describes the implant as the first and only transcatheter device approved in the U.S. specifically designed to treat PVL, giving physicians a minimally invasive option to close these leaks without requiring patients to undergo another open-heart surgery.

When diseased or damaged heart valves cannot be repaired, they may be replaced with either mechanical or tissue valves in an open-heart surgical procedure. Following heart surgery, a small gap between the native heart tissue and the replacement valve can remain or develop over time, and blood leaking through this gap is known as a paravalvular leak. Citing a 2014 study published in The Journal of Thoracic and Cardiovascular Surgery, Abbott states these 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 in which red blood cells are damaged, causing severe anemia. Abbott’s international product page for the device states that PVL can occur soon after valve replacement or several years later, and lists risk factors for PVL development including annular calcification, tissue friability, prior endocarditis or other inflammatory processes, and recent initiation of corticosteroid therapy.

The Amplatzer Paraclose is implanted through a catheter inserted through an artery or vein in the leg and is positioned within the leak to close it. Abbott states the device offers patients a minimally invasive treatment option to address PVL without requiring another surgery.

PARADIGM Study Supported the Approval

FDA approval of the Amplatzer Paraclose PVL Occluder was supported by positive clinical data from the PARADIGM study, which Abbott describes as a prospective, multicenter, single-arm study that includes 200 patients. Abbott states the study demonstrated that the device provides an effective, minimally invasive alternative to open-heart reoperation.

“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. He said the device’s elliptical shape is specifically designed to effectively close a wide range of PVL shapes and sizes, allowing many patients to avoid another cardiac surgery.

Sandra Lesenfants, senior vice president of Abbott’s structural heart business, said physicians treating PVL in the U.S. previously did not have an approved alternative to repeat open-heart surgery. “Offering this purpose-built device fills a critical unmet need,” she said, adding that the Amplatzer Paraclose 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.

Oblong Nitinol Design

The Amplatzer Paraclose has an oblong shape and design features intended to enable effective closure across diverse PVL anatomies. Abbott’s international product page for the device, which is sold outside the U.S. as the Amplatzer Valvular Plug III, describes the implant as self-expanding and made from braided Nitinol wires with shape memory characteristics. To close PVL of different morphologies, the device comes in a range of nine sizes and has a flexible Nitinol waist. Abbott states the device’s asymmetrical oblong shape is designed to fit a wide range of PVL and that it can provide effective closure in up to 93% of patients.

The Amplatzer portfolio of devices also includes the Amplatzer Piccolo Occluder and the Amplatzer Talisman PFO Occluder, which provide minimally invasive treatment options for the closure of congenital heart defects and for stroke risk reduction. Abbott states the Amplatzer line pioneered transcatheter cardiovascular and peripheral vascular occlusion, and its product page reports more than 1.25 million Amplatzer devices implanted worldwide and more than 20 years of clinical experience, with the implant total cited to data on file at Abbott.

The Amplatzer Valvular Plug III has been approved to treat PVL in Europe since 2020, according to the announcement.