FDA Approves Amplatzer Paraclose Device for Heart Leaks

The new transcatheter device provides a minimally invasive treatment option for patients with paravalvular leaks.

Updated on Oct. 28, 2026 in Heart Disease

Bold flat-color editorial illustration of an elliptical medical heart occluder, rendered in an institutional geometric register for health policy news. — The FDA has approved the Amplatzer Paraclose PVL Occluder, a new transcatheter device designed to repair paravalvular leaks in heart valve patients. AI Illustration. Upload story photo >

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The FDA has officially approved the Amplatzer Paraclose PVL Occluder to treat paravalvular leaks, a complication occurring in some heart valve replacements. The device offers a minimally invasive alternative to repeat open-heart surgery for affected patients.

Why it matters

Paravalvular leaks can lead to serious symptoms like fatigue and swelling, potentially requiring intervention. By providing a catheter-based solution, this device avoids the significant physical toll of secondary open-heart surgeries.

Paravalvular leaks occur in 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements. The device's efficacy was supported by the PARADIGM study, which included 200 patients.

The players

Food and Drug Administration

The federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of medical devices and drugs in the United States.

Cleveland Clinic

A prominent non-profit academic medical center that serves as a hub for complex cardiovascular research and specialized surgical procedures.

The details

The device features an elliptical design specifically created to seal diverse anatomical structures found in leaking valves. Implantation is performed by inserting the device through a catheter via a vein or artery in the leg.

The FDA approved the Amplatzer Paraclose PVL Occluder on October 28, 2026.

Health Landscape

The FDA approval follows the success of the PARADIGM study, which provides the clinical evidence required for new heart valve intervention tools. This milestone represents a shift toward less invasive procedures for common complications following valve replacement surgery.

Patients suffering from complications like fatigue and shortness of breath now have a pathway to treatment that avoids repeat open-heart surgery. This minimally invasive approach reduces recovery times and the risks traditionally associated with secondary cardiac operations.

The takeaway

Patients experiencing symptoms after valve replacement surgery should consult with their cardiologist to determine if this new catheter-based option is appropriate for their specific case. This approval highlights the ongoing transition toward less invasive medical technologies in cardiovascular health.