PALO ALTO, Calif., Jan. 11, 2011 /PRNewswire/ — Nfocus
Neuromedical, Inc., an innovative medical device company with a
focus on the next generation treatment for brain aneurysms, today
announced that the company received U.S. Food and Drug
Administration 510(k) clearance for its Acta™ Vessel
Occlusion System (VOS). The Acta VOS provides physicians with
a minimally-invasive alternative to current treatment options for
an array of common and potentially serious vascular lesions.
The Acta VOS is designed to occlude (close) targeted veins and
arteries with great precision. Vascular occlusion is often used to
block blood flow to malformed, weakened or leaking vessels, or to
benign or malignant tumors.
“The Acta VOS and the Nfocus technology platform on which it’s
based address an important and, to this date, insufficiently
resolved medical need,” said Eric Milledge, chairman and CEO,
Nfocus Neuromedical. “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™, our flagship product for treating brain
aneurysms.”
Vascular occlusions were historically accomplished by surgically
closing the targeted blood vessel – a traumatic and expensive
procedure. More recently, surgeons began placing small wire coils
and other vascular plugs through catheters to stop blood from
flowing to the area of concern. However, several coils may be
required to occlude a single vessel, and occlusions frequently
re-open. Pre-clinical studies demonstrate that the Acta VOS stops
blood flow in a vessel more quickly and durably than both coils and
a predicate plug device.
The Acta VOS uses a self-expandable, multi-layer oval implant
made from Nitinol, a nickel-titanium alloy. Nitinol’s properties
allow the device to easily compress within a conventional catheter,
and then rapidly open to full size once deployed
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