This article was originally published in The Gray Sheet
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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Abdominal aortic anuerysm endovascular graft is recalled from existing hospital inventories and production halted by the company due to deficiencies in regulatory processes associated with deployment of the device and communications with the FDA, company reports March 16. The recall leaves Medtronic's AneuRx as the only AAA stent graft currently available on the U.S. market. Both firms have encountered problems in the past related to deployment of AAA devices. In November 1999, Guidant conducted a Class II recall of 287 Ancure units after a failure in the manufactuing process caused problems in the deployment of the product's attachment system
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