Boston Scientific, Guidant and Endovascular Technologies began marketing the Ancure Endocraft System in the United States in 1999.
The Ancure Device was designed for use in the treatment of abdominal aortic aneurysms. An abdominal aortic aneurysm is a potentially life threatening condition involving a weak area that develops in the wall of the aorta, the artery that brings blood flow from the heart through the abdomen to the rest of the body. The Ancure Device sold by Guidant has two primary parts. The first part is a delivery catheter used to place the vascular endograft into the aorta. The delivery catheter is inserted into a blood vessel through an incision made in the plaintiffs leg. The second part of the Ancure Device is a vascular endograft placed in the patients aorta using a delivery system to prevent an aneurysm from rupturing. The vascular endograft consists of a woven fabric graft with an attachment system that includes hooks. The vascular endograft is designed to remain in the patients aorta permanently after being implanted to strengthen the weakened area in the aorta. The delivery catheter is designed to be removed from the patent after the vascular endograft is implanted. Traditionally, in order to treat abdominal aortic aneurysms, patients had to undergo invasive surgery requiring the physician to cut open the abdomen in order to reach the aorta.
Boston Scientific, Guidant and Endovascular Technologies removed the device from the market on March 16, 2001. The company made changes and put the device back on the market in August, 2001. On June 17, 2003, Guidant Corp. announced that it will stop making the device and close the California subsidiary that made the product. A total of 7,632 devices were sold prior to the recall, and 2,628 reported problems. Approximately 11,000 devices were sold after the recall.
Defendant Details
Name (Stock Symbol)
Brief Description
Guidant Corporation
Guidant Corporation merged with Boston Scientific and now operates under that name. It is a medical device manufacturer.
Boston Scientific Corporation (BSX)
Boston Scientific Corporation designs, manufactures and sells medical devices.
Endovascular Technologies, Inc.
Endovascular Technologies, Inc. is a medical device manufacturer. It is a wholly owned subsidiary of Guidant.