The FDA has just approved NeuroVasx, Inc.’s cPAX Aneurysm Treatment System through the Humanitarian Device Exemption (HDE), which allows for treatment of up to 4,000 patients a year. The EU CE marked device, which we have covered previously here at Medgadget, can attain better filling of aneurysms than traditional metal coil treatments because it is composed of a relatively softer material.
From the announcement:
cPAX is a polymeric strand delivered into the aneurysm using a technique similar to currently available platinum coil technologies. cPAX, because of its soft polymeric material, is designed to achieve more complete filling of the aneurysm with the probable benefit of greater long term stability. A significant feature of cPAX in comparison to currently available technologies is that it offers the physician the ability to detach the device at any point versus a fixed detachment zone common in platinum coils. The polymeric material also allows for non-invasive CT and MRI scans with little or no artifact for more accurate patient follow-up assessment.