Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T99-46 Sharon Snider: 301-827-6242
September 28, 1999
Consumer Inquiries: 888-INFO-FDA
Aortic aneurysms are weak bulging spots on the aorta, the largest blood vessel in the body. If an aneurysm enlarges and ruptures, it usually causes fatal internal bleeding.
Currently, major open abdominal surgery is required to implant a graft and prevent the bulge from rupturing. The two new devices, called endovascular grafts, allow these aneurysms to be treated using minimally invasive procedures.
The new products are the Ancure Tube and Bifurcated Endovascular Grafting Systems, made by Guidant EndoVascular Technologies, Inc., of Menlo Park, Calif., and the AneuRx (Bifurcated) Stent Graft System, made by Medtronic AVE, of Santa Rosa, Calif.
The endografts are positioned into the aneurysm using a catheter that is inserted through an artery in the groin and advanced into the abdominal aorta. The physician uses x-ray imaging to guide the endograft into place.
The devices provide an alternative pathway for blood to flow through the aorta without filling the aneurysm, thereby reducing pressure on the aneurysm with the intent of preventing it from bursting.
FDA based approval of the devices on clinical studies of safety and effectiveness conducted by the manufacturers and on the recommendation of the Circulatory System Devices Panel of FDA's Medical Devices Advisory Committee, a group of outside experts.
In clinical studies, the Guidant devices, which come in tubular or branched form, were used to treat 421 patients with abdominal aortic aneurysms at 22 medical centers in the United States. They were compared to 111 patients who were treated through open abdominal surgery.
The endografts were successfully inserted in 91 percent of patients. The studies showed that patients treated with the endografts had a lower rate of major complications and shorter hospital stays than those who had standard abdominal surgery.
The Medtronic system, which is a modular system comprised of a branched component and an additional limb, was used to treat 416 patients at 13 medical centers in the United States. They were compared to 66 patients who had open abdominal surgery.
The endograft was successfully inserted in 98 percent of patients. The patients experienced fewer serious, procedure- related adverse events and less blood loss and were discharged earlier from the hospital than those who had standard abdominal surgery.
As conditions of approval, FDA is requiring both companies to conduct additional studies on the long-term safety and effectiveness of these devices and maintain a training and proctoring program.