Consumer Groups Say Aneurysm Fixer Needs More FDA Tests

Law360, New York (February 29, 2012, 6:48 PM EST) -- Consumer, patient and public health groups on Wednesday urged the U.S. Food and Drug Administration to yank its approval of Aptus Endosystems Inc.'s suturing system used to repair aortic aneurysms, claiming the agency skipped testing that determines if life-saving medical devices are safe and effective.

The groups — which include the Consumers Union, the National Research Center for Women & Families and the American Medical Women’s Association — maintain that the FDA should have classified Aptus' HeliFX Aortic Securement System as high-risk and subjected it to...
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