Abbott has received US Food and Drug Administration (FDA) approval for its Amplatzer™ Paraclose Paravalvular Leak (PVL) Occluder, the first and only transcatheter device approved in the United States specifically designed to treat leaks around surgically replaced heart valves.
The device provides a minimally invasive alternative to repeat open-heart surgery for patients with paravalvular leaks.
Paravalvular leaks occur when a gap develops between the natural heart tissue and a replacement heart valve, allowing blood to flow backwards. The condition can cause symptoms associated with heart failure, including breathlessness, fatigue and swelling, and may also result in damage to red blood cells.
The Amplatzer Paraclose device is delivered through a catheter inserted into an artery or vein in the leg. Its oblong shape and elliptical design allow it to accommodate different leak shapes and sizes, supporting closure without requiring another open-heart operation.
The FDA approval was supported by clinical evidence from the PARADIGM study, a prospective, multicentre, single-arm investigation involving 200 patients. The findings supported the device's safety and effectiveness as a minimally invasive treatment option.
The Amplatzer Paraclose PVL Occluder has received FDA approval for treating paravalvular leaks in the United States.
