FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks

Abbott has received U.S. Food and Drug Administration approval for its Amplatzer Paraclose PVL Occluder, a minimally invasive device designed to treat leaks that develop around surgically implanted replacement heart valves.

The approval makes Amplatzer Paraclose the first and only transcatheter device specifically approved in the U.S. for treating paravalvular leak.

Paravalvular leak occurs when a gap remains or develops between a replacement heart valve and the surrounding native heart tissue, allowing blood to flow backwards around the implanted valve.

The condition can occur following both mitral and aortic valve replacement.

Abbott said paravalvular leaks affect approximately 7% to 17% of patients following mitral valve replacement and between 5% and 10% following aortic valve replacement.

The condition can contribute to symptoms associated with heart failure, including shortness of breath, fatigue and swelling in the legs and feet.

It can also cause haemolysis, where red blood cells are damaged, potentially leading to severe anaemia.

The Amplatzer Paraclose device is delivered through a catheter inserted into an artery or vein in the leg, offering an alternative to repeat open-heart surgery.

Its oblong design is intended to accommodate the different shapes and sizes of paravalvular leaks that can occur around replacement valves.

Amar Krishnaswarmy, MD, Section Head of Invasive and Interventional Cardiology at Cleveland Clinic, said the approval addresses an important treatment gap for patients experiencing paravalvular leak.

He said the device’s elliptical design allows physicians to treat a range of leak anatomies while potentially avoiding the need for another cardiac operation.

FDA approval was supported by results from the PARADIGM study.

The prospective, multicentre, single-arm study included 200 patients and evaluated the safety and effectiveness of the Amplatzer Paraclose PVL Occluder as a minimally invasive treatment for paravalvular leak.

Abbott said the results supported the device as an alternative to surgical reoperation.

Sandra Lesenfants, Senior Vice President of Abbott’s structural heart business, said physicians in the U.S. previously lacked an approved device specifically designed to treat paravalvular leaks without repeat surgery.

She said the approval expands Abbott’s portfolio of minimally invasive structural heart technologies aimed at treating cardiovascular conditions while reducing the need for more invasive surgical procedures.

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