MAPLE GROVE, Minn., April 5, 2011 /PRNewswire/ —
NeuroVasx announced today that the FDA has approved the cPAX
Aneurysm Treatment System as a Humanitarian Use Device (HDE) for
the treatment of large, giant and wide-neck cerebral aneurysms,
which are typically the most difficult to treat. The HDE
allows for the treatment of up to 4,000 patients per year in the
U.S.
(Logo: http://photos.prnewswire.com/prnh/20110405/CG77724LOGO)
Christopher Dowd, M.D., Clinical Professor of
Neuro-Interventional Radiology at the University of California at
San Francisco and Medical Director for NeuroVasx, Inc., said, “The
large, giant and wide-neck cerebral aneurysm population continues
to remain the most challenging to treat. cPAX will offer
physicians an alternative solution that we believe can make a
significant impact in treatment and outcome for these patients.”
Ricardo Hanel, M.D., PhD, Associate Professor of Neurosurgery
at the Mayo Clinic in Jacksonville, Florida and Co-Principal
Investigator in the cPAX Clinical Trial, states, “The longer term
stability we have seen in the clinical studies using cPAX in larger
aneurysms gives me great confidence in the positive impact this
product will have on the care of our patients.”
A cerebral aneurysm is an abnormal bulge or sac in the wall of
an artery in the brain which can be caused by a number of factors
including congenital defects, high blood pressure, atherosclerosis,
cancer, drug use or head trauma. If a cerebral aneurysm
ruptures, it can lead to a hemorrhagic stroke, or bleeding on the
brain. According to the National Institutes of Health,
approximately 40% of these patients do not survive the first 24
hours. The worldwide incidence of cerebral aneurysms is
estimated to be 320,000 annually, approximately 200,000 of which
may be treatable with intracranial surgery using minimally invasive
technique
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