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FDA Permits Marketing of a System to Repair Failed, Problematic Fix for Aortic Aneurysms
Date:11/21/2011

eview of data from 154 patients who were implanted with 810 EndoStaples. Patients were monitored with routine followup CT scans. After a year, none of the EndoStaples had fractured and no patients experienced endograft movement (migration); one subject needed an additional intervention to address an endoleak.

The Aptus EndoStapling System is for use in patients whose endovascular grafts have moved, exhibit endoleaks, or are at risk for these complications and additional intervention is needed to reattach the graft and seal off the aneurysm.

The Aptus EndoStapling System is manufactured by Aptus Endosystems Inc. of Sunnyvale, Calif.

For more information:
FDA: Medical Devices
http://www.fda.gov/MedicalDevices/default.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.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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