Abbott announced that it has received U.S. Fooding and Drug Administration (FDA) approval for a new catheter-based device designed to close small gaps that may form between heart tissue and the new valve after heart valve replacement surgeries, a condition known as paravalvular leak.
Details of the Medical Condition and the New Device
These leaks occur in percentages ranging from 7% to 17% in mitral valve replacement procedures, and from 5% to 10% in aortic valves. The Amplatzer Paraclose PVL Occluder is the first minimally invasive device approved in the United States to close these gaps, providing patients with a mechanical alternative that spares them from undergoing additional open-heart surgery.
According to Abbott, these leaks can cause symptoms including shortness of breath, swelling of the legs and feet, as well as damage to red blood cells. The new device is implanted via catheter through the leg arteries or veins.
What the Approval Means in Practice
The FDA approval was based on positive clinical data derived from the PARADIGM study, a prospective, multicenter study involving 200 patients, which demonstrated that the device represents an effective alternative to repeated open-heart surgeries. The company plans to present the 30-day results of this study at the Transcatheter Cardiovascular Therapeutics conference in San Diego.
Expanding the Medical Portfolio
The Amplatzer Paraclose device is the latest addition to Abbott's lineup of minimally invasive Amplatzer devices, which also includes a device for closing congenital heart defects and reducing stroke risks. It is worth noting that outside the United States, the device is known as the Amplatzer Vascular Plug III, and it has received regulatory approvals for use in Europe since 2020, while the company continues to develop and market other advanced cardiovascular technologies.