Nfocus Neuromedical, a medical device company focusing on brain aneurysms treatment, has received the US Food and Drug Administration 510(k) clearance for its Acta Vessel Occlusion System (VOS).
The Acta VOS uses a self-expandable, multi-layer oval implant made from Nitinol, a nickel-titanium alloy, which allows the device to easily compress within a conventional catheter, and then rapidly open to full size once deployed within a vessel.
The Acta VOS is designed to occlude (close) targeted veins and arteries with great precision and is mounted on a delivery system that allows physicians to easily retract and reposition the device.
The Acta VOS provides physicians with a minimally-invasive alternative to current treatment options for an array of common and potentially serious vascular lesions.
Nfocus Neuromedical chairman and CEO Eric Milledge said the Acta VOS and the Nfocus technology platform on which it is based address an important and, to this date, insufficiently resolved medical need.
"The Acta 510(k) clearance is a tangible demonstration of our company’s progress and is the first step toward clearance of the Nfocus platform of braided occluders, which includes the Luna, flagship product for treating brain aneurysms," Milledge said.