FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: cPAX Aneurysm Treatment System
Manufacturer: Neurovasx, Inc
Address: 7351 Kirkwood Lane North, Suite 112, Maple Grove, MN 55369
Approval Date: April 1, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/h100002a.pdf
What is it? The cPAX Aneurysm Treatment System is used to treat aneurysms (localized, blood-filled ballooning areas in the wall of a blood vessel) in the brain that are particularly difficult to manage because of their size and shape (wide-necked large and giant-sized cerebral aneurysms greater than 10 mm). The system consists of a material used to fill the aneurysm (cPAX polymeric implant material), a device (D3) which is used to deliver and detach the filling material into the aneurysm, and a cPAX Jumper Cable and Power Supply that are used to deliver energy to the D3 device to detach the filler material into the aneurysm.
How does it work? The cPAX implant material is delivered through a catheter in a blood vessel up into the aneurysm within the brain. Other devices such as stents or small balloon-type devices are used to keep the cPAX implant material trapped within the aneurysm. By filling up the space within the aneurysm with the implant material, the blood flow through the aneurysm is stopped; any remaining spaces around the implant material become filled with blood clot. When blocked off (occluded) with implant material and blood clot, the risk of rupture of the aneurysm decreases and it may shrink over time.
When is it used? This system is used for the treatment of adults (age 22 years and older) with aneurysms that are difficult to manage because of their size and shape (wide-necked large and giant-sized cerebral aneurysms greater than 10 mm). It is a less invasive treatment, performed with the use of a catheter placed inside the blood vessel, compared to an open surgical procedure with the use of clips to occlude the aneurysm.
What will it accomplish? By filling the aneurysm with the cPAX implant material and blood clot, treatment with the cPAX Aneurysm Treatment System is intended to reduce the likelihood of aneurysm rupture or increase in size of the aneurysm, which also increases its risk of rupturing. A successfully treated aneurysm will often shrink over time.
When should it not be used? This device system should not be used in patients with active infection or in patients in whom anticoagulation and antiplatelet therapy (such as aspirin) is contraindicated.
Additional Information: Summary of Safety and Probable Benefit and labeling are available online.