New device closes valve leaks without repeat surgery

Clinical takeaway: Consider referral for transcatheter closure assessment in patients with paravalvular leak (PVL) after surgical valve replacement, particularly those with heart failure symptoms or hemolysis. Abbott’s newly approved Amplatzer Paraclose PVL Occluder offers a minimally invasive treatment option that may help patients avoid repeat open-heart surgery.

PVL occurs when blood leaks around, rather than through, a replacement heart valve. These leaks develop in an estimated 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements and can cause heart failure symptoms, hemolytic anemia, and reduced quality of life.

FDA has approved Abbott's Amplatzer Paraclose PVL Occluder, the first and only transcatheter device in the US specifically indicated for treatment of paravalvular leak around surgically implanted heart valves.

The device is delivered through a catheter inserted via an artery or vein in the leg and positioned within the leak to seal the abnormal opening. Abbott says its oblong, elliptical design was developed to accommodate the wide range of PVL shapes and sizes encountered in clinical practice.

Approval was supported by findings from the PARADIGM study, a prospective, multicenter, single-arm trial involving 200 patients. According to the company, the study demonstrated that the device provides an effective, minimally invasive alternative to repeat open-heart reoperation, which has traditionally been the primary treatment option for clinically significant PVL.

The device addresses an unmet need in the US, where clinicians previously lacked an FDA-approved transcatheter therapy specifically designed for PVL closure, despite years of off-label and international use of related technologies.

"The U.S. approval of the Amplatzer Paraclose PVL Occluder addresses a significant treatment gap for people suffering from a paravalvular leak," said Amar Krishnaswamy, MD, of the Cleveland Clinic. "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."

Source: Abbott. (2026 Oct 28) FDA approves first and only device in the U.S. to treat paravalvular leaks after heart valve replacement without additional surgery