Abbott’s Amplatzer Paraclose Occluder has secured US Food and Drug Administration (FDA) approval, making it the first transcatheter device approved in the US market that is specifically designed for paravalvular leak (PVL) treatment.

PVL, a situation that occurs when a gap forms between a replacement heart valve and the surrounding heart tissue, allows blood to flow backward around the valve. Severe leakage cases can result in symptoms associated with heart failure such as shortness of breath, along with severe anaemia, and can necessitate revision heart surgery if the administration of diuretics or vasodilators prove ineffective.

Revision surgery tends to be necessary in serious PVL cases, whereas Amplatzer Paraclose, implanted through a catheter inserted through an artery or vein in the leg, offers patients a minimally invasive treatment option to address PVL without requiring another surgery, Abbott stated.

Amplatzer Paraclose’s FDA approval was supported by data from Abbott’s PARADIGM (NCT04489823) study, which demonstrated that the device provides a safe, effective alternative to repeat open-heart surgery. Meanwhile, the device has been available in Europe, marketed as the Amplatzer Valvular Plug III, since 2020.

According to the American Heart Association (AHA), PVL affects between 2% and 18% of patients following heart valve replacement surgery or transcatheter valve procedures, with incidence rates depending on whether the valve is in the aortic or mitral position and whether it was placed surgically or via catheter.

“Offering this purpose-built device fills a critical unmet need as physicians treating PVL in the US previously didn’t have an approved alternative to repeat open-heart surgery,” said 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,” Lesenfants continued.

Other tools within Abbott’s Amplatzer portfolio include the Piccolo Occluder for patent ductus arteriosus (PDA) closure in premature infants and Talisman patent foramen ovale (PFO) for closing the PFO, a small flap-like opening between the upper chambers of the heart that can fail to close properly after birth. These devices were FDA-approved in January 2019 and September 2021, respectively.