Ancure

    The Ancure device also known as stent graft was developed by the company EVT and now is produced and commercialized by Guidant. Ancure device used to treat abdominal aortic aneurysm without traditional surgical techniques. Ancure medical device, part of the Ancure Endograft System, uses a catheter to insert a sheath through the femoral artery in the leg. Ancure was marketed as allowing physicians to repair bulges in the aorta without performing a major open surgery which can have significant complications.

    Ancure device was made by Endovascular Technologies of Menlo Park, California, a subsidiary of Indianapolis-based Guidant Corporation.

    On June 12, 2003, federal prosecutors charged Endovascular Technologies with 10 felony counts, including false statements to the Food and Drug Administration (FDA) in connection with the Ancure device. The complaint filed by federal prosecutors alleged that the Ancure device often malfunctioned and Guidant asked doctors to use it in ways not approved by the government. The company was charged with two counts of failing to report as many as 2,600 malfunctions of the Ancure device, thus preventing the public and physicians from learning about "recurring malfunctions and other risks." The company was also accused of failing to report that other, more invasive operations were required after the Ancure failed. The same day the complaint was filed, Endovascular Technologies plead guilty to the charges.