Abbott’s Amplatzer Paraclose PVL Occluder Approved by FDA

October 29, 2026—Abbott announced it has received FDA approval for the Amplatzer Paraclose paravalvular leak (PVL) occluder.

According to the company, the transcatheter Amplatzer Paraclose device, which is specifically designed to treat PVL, has an oblong shape and design features that enable effective closure across diverse PVL anatomies.

Abbott stated that FDA approval for the Amplatzer Paraclose PVL occluder was supported by clinical data from the PARADIGM study. The prospective, multicenter, single-arm study enrolled 200 patients, demonstrated that the Amplatzer Paraclose provides an effective, minimally invasive alternative to open-heart reoperation, noted the press release.

“The United States approval of the Amplatzer Paraclose PVL occluder addresses a significant treatment gap for people suffering from a paravalvular leak,” commented Amar Krishnaswarmy, MD, from the Cleveland Clinic in Cleveland, Ohio, in Abbott’s press release. “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.”

Outside of the United States, the Amplatzer Paraclose PVL occluder is known as the Amplatzer Valvular Plug III, which has been approved to treat PVL in Europe since 2020, stated Abbott.