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Guidant's Ancure

This article was originally published in The Gray Sheet

Executive Summary

FDA is permitting implants of the abdominal aortic aneurysm stent graft on a "compassionate use" basis while the company conducts a recall of the product from hospitals, Guidant reports following a March 23 meeting with FDA. Problems related to the deployment of the minimally invasive system led to a March 16 announcement that the company would stop production and sales of the device (1"The Gray Sheet" March 19, 2001, In Brief) and take a $12-15 mil. charge to first-quarter earnings. Discussions with FDA are ongoing, Guidant says

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