"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 study tracked 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/M
|SOURCE U.S. Food and Drug Administration|
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