#6 Implantable Device to Treat Complex Brain Aneurysms

Overview

An aneurysm in the brain, also called a cerebral aneurysm or an intracranial aneurysm, is a weakened area in the middle layer of the wall of a blood vessel in the brain that causes an abnormal ballooning or widening. It’s estimated that up to one in 15 people in the United States will develop a brain aneurysm in their lifetime. Aneurysms can occur in people of all ages, but are most commonly detected in those ages 50 to 60.

Patients with aneurysms are born with a weakness in one or more spots in the arteries in the brain. Due to the weakened arterial wall, there is a risk for tearing or bursting of the aneurysm—a rupture—as it increases in size over decades. This can lead to a hemorrhagic stroke, permanent neurological deficits, or death. The American Associaton of Neurological Surgeons estimates that 30,000 Americans experience a ruptured brain aneurysm annually.

When a small aneurysm is discovered, it can be treated with a major surgical procedure in which the skull is opened and special clips are used to clamp blood flow to the aneurysm. It can also be treated using a catheter and threading metallic coils into the blood vessel in the brain that contains the aneurysm. This causes it to clot, effectively destroying the aneurysm.

Unfortunately, these two methods can’t be used for large and difficult-to-treat aneurysms, particularly those an inch or more in diameter with a wide neck, which is the opening of the aneurysm. These aneurysms are some of the most complex and dangerous and have remained a significant unmet clinical need. When left untreated due to the size and location, these aneurysms can compress the brain, bleed, cause ischemic strokes, and death.

However, there is now a new minimally-invasive procedure available that can safely and effectively treat these aneurysms without open surgery by implanting a new FDA-approved device directly into the artery. Consisting of a flexible braided mesh tube made of platinum and nickel-cobalt chromium alloy, this device can be delivered by catheter and used to block off large, giant, or wide-necked aneurysms in the damaged internal carotid artery. This is the major blood vessel that supplies blood to the front of the brain.

When placed across the neck of the aneurysm, the device redirects blood flow away from the aneurysm to the uncompromised part of the blood vessel. The blood that remains in the aneurysm forms a clot, preventing the aneurysm from rupturing and, over time, may eventually cause it to shrink. Study evidence presented to the FDA reported that 70 percent of the aneurysms remain obstructed and without significant arterial stenosis a year after implantation of this remarkable new device. Since the device is inserted though a tiny incision in the femoral artery of the leg, patients typically leave the hospital the day after the procedure. It’s been estimated that over the next five years, approximately one fourth of worldwide aneurysm treatment procedures could be eligible for treatment with this device.

Where Are They Now

The device has proven to be superior to older forms of coiling and stenting because it forms a fabric sleeve inside the blood vessel that allows blood to move away from the aneurysm, forming a new blood vessel inside of the aneurysm. Over time, the aneurysm will heal around the stent and vanish. Over 90 percent total obliteration rates at 12 months have been consistently confirmed in international studies. Because it helps reconstruct blood vessels within the brain, experts feel that this device may one day replace traditional open brain procedures. 
  
An updated version of this technology with an advanced delivery system was recently approved by the FDA in February 2015 to increase the accuracy and improve control during the procedure. Several other advanced versions of this technology have entered the market, with the most recent receiving CE Mark approval in 2017.

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