FDA Approves ev3 Inc.'s New Device to Treat Brain Aneurysms
An aneurysm is a weak, enlarged area in an artery (blood vessel). Over time, the force of normal blood pressure can cause it to rupture, which can be life-threatening and cause significant disability in survivors. The American Association of Neurological Surgeons estimates that every year 30,000 people in the United States experience a ruptured brain aneurysm. Aneurysms are more prevalent in people ages 50 to 60 and three times more prevalent in women.
The size of an aneurysm can vary from small (less than .25 inches) to giant (larger than 1.25 inches). Its shape may also vary; for example, it may be balloon-like with a narrow neck extending from the artery or it may resemble a bulge with a wide or indistinct neck.
The Pipeline Embolization Device (PED) is a flexible mesh tube made of platinum and nickel-cobalt chromium alloy that can be used to block off large, giant, or wide-necked aneurysms in the internal carotid artery, a major blood vessel supplying blood to the front of the brain. The device can also reduce the likelihood that an aneurysm will rupture.
To implant the device, the Pipeline is attached to the end of a catheter, which is inserted into an artery in the leg. The catheter is threaded into the carotid artery and into position at the aneurysm where the Pipeline is expanded against the walls of the artery and across the neck of the aneurysm, cutting off blood flow to the aneurysm. The blood remaining in the blocked-off aneurysm forms a clot which reduces the likelihood the aneurysm will grow bigger or rupture. Aneurysms successfully treated with the Pipeline will often shrink over time.
"The Pipeline Embolization Device offers neurointerventional surgeons an alternative to open surgery or placement of materials such as coils or a liquid embolic when treating carotid artery brain aneurysms," said Christy Foreman, acting director, Office of Device Evaluation, Center for Devices and Radiological Health.
As part of the approval process, the FDA reviewed results from a study that followed 108 patients between ages 21 and 75 who had a large or giant aneurysm with no discernable neck in certain sections of the internal carotid artery. Results showed that one year after implantation 70 percent of aneurysms remained blocked off without significant narrowing (stenosis) of the section of the artery treated with the Pipeline device.
The same studytracked adverse events associated with the Pipeline and showed that ten strokes occurred in 9 patients in the year after treatment, significantly less than the 20 percent rate expected for this condition. Patients also experienced minor adverse events such as headache, bleeding, nausea and vision problems.
The Pipeline should not be used in patients with an active infection or patients who cannot take antiplatelet therapy (medication that interferes with blood clotting), such as aspirin. Patients should receive adequate antiplatelet therapy prior to surgery to place the Pipeline. The Pipeline device should not be used to treat an aneurysm with a stent previously placed across its neck.
The Pipeline Embolization Device is manufactured by ev3 of Menlo Park, Calif.
For more information:
FDA: Medical Devices
FDA: Device Approval and Clearance http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm
NIH: Aneurysm in the Brain http://www.nlm.nih.gov/medlineplus/ency/article/001414.htm
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration