FDA clears device to fix leaky heart valves

Abbott announced Wednesday that the FDA cleared its Amplatzer Paraclose PVL Occluder, marking the first U.S. approval for a catheter-based solution to seal leaks forming between heart tissue and surgically implanted replacement valves.

The device treats paravalvular leak after valve replacement surgery, sparing patients from another open-heart surgery.

Paravalvular leaks occur in 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements, causing symptoms such as shortness of breath and swelling of the legs and feet.

The Amplatzer Paraclose PVL Occluder is the first minimally invasive device approved in the U.S. to close these leaks, offering an alternative to additional open-heart surgery.

Sandra Lesenfants, senior vice president of Abbott’s structural heart business, states that the device fills a critical unmet need, allowing many patients to avoid the risks of another surgery.

FDA approval was supported by positive clinical data from the PARADIGM trial, a prospective, multicenter, single-arm study of 200 patients, which showed the device is an effective, minimally invasive alternative to repeat open-heart surgery.

Abbott will present 30-day results from the trial at the upcoming Transcatheter Cardiovascular Therapeutics conference in San Diego.

The Amplatzer Paraclose device is the latest addition to Abbott’s portfolio of minimally invasive Amplatzer devices, including the Piccolo Occluder and Talisman PFO Occluder.

Outside of the U.S., the device has been approved to treat paravalvular leaks in Europe since 2020, where it is known as the Amplatzer Valvular Plug III.