Photo: Jerry Hecht/NIH, public domain
Abbott said Wednesday it received U.S. approval for a catheter-delivered device to close serious leaks around replacement heart valves, giving eligible patients an alternative to repeat open-heart surgery.
The Amplatzer Paraclose PVL Occluder is approved for clinically significant paravalvular leaks associated with surgical aortic or mitral valve prostheses, according to the company’s October 28 announcement and U.S. safety information. The approval is not a blanket indication for every leak or every type of heart valve.
A paravalvular leak occurs when blood flows through a gap between the patient’s own heart tissue and a replacement valve. The gap can remain after surgery or develop later. Abbott said such leaks can cause symptoms associated with heart failure, including shortness of breath, fatigue and leg swelling, or damage red blood cells and cause anemia.
A catheter route instead of another open operation
The device is delivered through a catheter inserted into an artery or vein in the leg and positioned within the leak to close it. Its oblong shape is designed to address different leak shapes and sizes.
Abbott describes it as the first U.S.-approved transcatheter device specifically designed for this use. That is a U.S. regulatory claim, not a worldwide first: the company says the device is known outside the U.S. as the Amplatzer Valvular Plug III, approved to treat paravalvular leaks in Europe since 2020.
The FDA approval was supported by PARADIGM, a prospective, multicenter, single-arm study involving 200 patients, Abbott said. A single-arm study does not by itself establish that the device is superior to repeat surgery or another treatment.
Eligibility and serious risks still matter
Not every patient is eligible. The safety information lists contraindications including active endocarditis or another systemic infection requiring treatment, a rocking valve, an extensive leak involving more than half of the valve perimeter, and certain masses or blood clots that could interfere with implantation.
It also excludes patients whose access site cannot accommodate the required sheath and those whose leak’s short axis exceeds 5 millimeters.
The procedure carries serious risks. The company’s safety information lists stroke, bleeding, device movement or embolization, interference with valve function, emergency surgery or later reoperation, and death among potential adverse events. A less-invasive procedure is not a risk-free one.
The announcement does not give a price, insurance-coverage terms or a launch date. Approval therefore should not be read as a guarantee that a particular patient can receive the device immediately or that an insurer will pay for it.
JBizNews Desk | Health Business
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