Healthcare Industry News: abdominal aortic aneurysm
News Release - September 29, 2006
Medtronic Comment on FDA Warning LetterMINNEAPOLIS--(HSMN NewsFeed)--Medtronic confirmed today it is has received an FDA Warning Letter dated September 27, 2006, regarding the delayed filing of a postmarket surveillance interim report on the AneuRx® Stent Graft System.
Medtronic has been actively working with the U.S. Food and Drug Administration (FDA) to submit the interim report in a manner that will meet the FDA's postmarket surveillance reporting requirements. The Warning Letter is not related to the quality, design or manufacture of the AneuRx product.
The interim postmarket surveillance report is a routine filing and has been issued annually since 2002 by Medtronic to report the results of a Postmarket Approval study of patients with the AneuRx Stent Graft System. The Postmarket Approval study, which began in 2002, was undertaken to make sure the AneuRx device is appropriately labeled for use in carefully designated patient populations for which the risk-benefit profile is known to be favorable, and to confirm the necessary training and experience for users of the AneuRx device.
The AneuRx Stent Graft System has been commercially approved since 1999 and is used to treat patients suffering from life-threatening abdominal aortic aneurysms (AAA). The AneuRx device has a proven safety record and is among the most implanted AAA devices on the market. Medtronic looks forward to the prompt resolution of this matter with the FDA.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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