cPAX Aneurysm Treatment System Approved for Treatment of Large Aneurysms

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Yesterday, the U.S. Food and Drug Administration (FDA) announced they have approved the cPAX Aneurysm Treatment System for surgery on brain aneurysms that are difficult to manage because of their size and shape.

An aneurysm is a bulge in the wall of a blood vessel. Brain aneurysms are also referred to as cerebral aneurysms. Over time, the pressure of the blood flow within the artery against the thinned bulging portion of the wall can enlarge the aneurysm. This pressure may cause the aneurysm to rupture, causing hemorrhage or death.

Brain aneurysms often produce no symptoms until they grow and press on nerves in the brain, or until they begin to leak blood or rupture.

Aneurysm repair can be done in two ways: 1) the surgeon can close the base of the aneurysm with a surgical clip, or 2) use a technique commonly known as coiling. In coiling, the surgeon uses a catheter to thread metallic coils through a blood vessel in the groin and into the blood vessel in the brain that contains the aneurysm. The surgeon then fills the aneurysm with the detachable coils, which block it from circulation and causes the blood to clot, effectively destroying the aneurysm.

Clipping or coiling techniques are difficult to use in aneurysms larger than 10 millimeters. The cPAX Aneurysm Treatment System is indicated for use in those brain aneurysms.

“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.”

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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, and the risk of rupture of the aneurysm decreases.

The cPAX Aneurysm Treatment System was approved on April 1, 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.

The cPAX 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.

According to the Brain Aneurysm Foundation, an estimated 6 million people in the United States have an unruptured brain aneurysm, or 1 in 50 people. They are most prevalent in people ages 35 - 60, but can occur in children as well. Most aneurysms develop after the age of 40.

The cPAX Aneurysm Treatment System is manufactured by Neurovasx Inc., Maple Grove, Minn

Source
FDA Press Release
Brain Aneurysm Foundation

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