FDA Approves NeuroVasx cPax Cerebral Aneurysm System Under HDE

April 5, 2011—NeuroVasx, Inc. (Maple Grove, MN) announced that the US Food and Drug Administration (FDA) has approved the cPax aneurysm treatment system under a humanitarian device exemption (HDE) for the endovascular treatment of large, giant, and wide-neck cerebral aneurysms.

“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,” commented Ricardo Hanel, MD, coprincipal investigator of the cPax clinical trial.

The FDA's HDE approval was based on safety data from two studies of 43 patients. The approved indication of the cPax system is for use in patients ≥ 22 years of age, and it should not be used in patients with an active infection or in those in whom anticoagulation and antiplatelet therapy is contraindicated. The HDE allows for the treatment of up to 4,000 patients per year in the United States.

According to NeuroVasx, cPax is a polymeric strand delivered into the aneurysm using a technique similar to platinum coil technologies. Because of its soft polymeric material, cPax is designed to achieve more complete filling of the aneurysm with the probable benefit of greater long-term stability. The cPax system allows the interventionist to detach the device at any point in contrast to the fixed detachment zones of platinum coils. The polymeric material also allows for noninvasive computed tomography and magnetic resonance imaging scans with little or no artifact for more accurate patient follow-up assessment, the company stated.