Guidant Signs "Corporate Integrity Agreement" with Justice Department

July 3, 2003
Medical device manufacturer Guidant has signed a "corporate integrity agreement" as the last step of a $92.4 million settlement with the Justice Department.

In June, Guidant subsidiary Endovascular Technologies pleaded guilty to 10 federal felony counts over allegations that the company lied to the government and hid 2,628 cases in which the delivery system on the Ancure Endograft System, an aortic-aneurysm stent-graft, malfunctioned or led to deaths or serious injuries.

Guidant removed the Ancure device, first introduced in 1999, from the market in March 2001 to make revisions and reintroduced the device in August 2001.

In the 19 months before the withdrawal of the Ancure device, Guidant reported 172 malfunctions to the FDA; however, federal prosecutors said that Guidant had received reports of 2,628 malfunctions, which led to 12 deaths and 57 cases that required emergency surgery.

Under the agreement, reached with the HHS Office of Inspector General, Guidant will have to maintain a compliance program with Endovascular Technologies, effective immediately.