The US Food and Drug Administration has approved the cPAX aneurysm treatment system for surgery on brain aneurysms that are difficult to manage because of their size and shape.
The cPAX (Neurovasx) is indicated for use in aneurysms larger than 10 milimetres, up to now these aneurysms have been difficult to treat with clipping or coiling.
“Like coiling, the cPAX aneurysm treatment system is a form of endovascular repair,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s center for Devices and Radiological Health. “But instead of tiny metallic coils, it uses a special polymer material to fill the space within the aneurysm.”
The cPAX polymeric filler material can be secured in the aneurysm in one of two ways, either by insertion through openings in a permanent stent, which is a tiny metal scaffold placed along the vessel wall, or by using a temporary balloon catheter to block off the opening to the aneurysm and keep the filler material from coming out of the aneurysm as it is being delivered.
By filling the bulging space within the aneurysm with implant material, the blood flow through the aneurysm is stopped and any remaining space around the implant material clots. When filled with implant material and blood clot, the risk of rupture of the aneurysm decreases.
This device system is indicated for use in adults ages 22 and older and should not be used in patients with an active infection or in those in whom anticoagulation and antiplatelet therapy is contraindicated.
The cPAX aneurysm treatment system was approved on 1 April 2011, under a Humanitarian Device Exemption (HDE). The HDE makes medical devices available to patients with rare medical conditions that affect fewer than 4,000 people a year. The approval for this HDE was based on safety data from two studies of 43 subjects.