FDA approves transcatheter device for treating PVL after heart surgery for first time
Abbott has secured U.S. Food and Drug Administration (FDA) approval for its Amplatzer Paraclose PVL Occluder, a new transcatheter device specifically designed to treat paravalvular leak (PVL) following heart valve surgery.
PVL is a known complication after valve replacement surgeries as well as transcatheter valve replacement procedures. It occurs when the new valve is implanted in a way that leaves a small gap that blood can then pass through.
The Amplatzer Paraclose PVL Occluder is the first device of its kind to ever receive FDA approval. It is delivered through an artery or vein in the leg, no additional open-heart surgery required, and it is positioned within the PVL to close the leak.
The FDA’s decision to approve the device was based on data from PARADIGM, a multicenter study of 200 patients who underwent an aortic or mitral valve replacement surgery.
“The U.S. approval of the Amplatzer Paraclose PVL Occluder addresses a significant treatment gap for people suffering from a paravalvular leak,” Amar Krishnaswarmy, MD, section head of invasive and interventional cardiology in the Robert and Suzanne Tomisch Department of Cardiovascular Medicine within Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute. “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.”
“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,” added 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.”
The Amplatzer Paraclose PVL Occluder has been approved and available as a treatment for PVL in Europe since 2020. However, it is known as the Amplatzer Valvular Plug III throughout that market.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.