More than a million people in the United States have a "silent killer" lingering in their bodies.
Called an abdominal aortic aneurysm, this dangerous bulge in the body’s largest artery usually has no symptoms — unless it ruptures, a condition that is often deadly.
Fridley-based Medtronic inc. said Tuesday that the Food and Drug Administration approved its Endurant AAA Stent Graft System to address the condition. Endurant is a stent made of a flexible wire frame sewn into a fabric tube that is used to create a new pathway for blood flow in the patient’s aorta.
The device is inserted in a minimally invasive manner, through the blood vessels in the groin. Medtronic claims Endurant is easier for doctors to use than similar devices, and it conforms better to each patient’s unique anatomy.
Women and people with smaller bodies are good candidates for the device, which costs roughly $15,000 to $20,000 per procedure.
About 75 percent to 90 percent of undiagnosed AAA patients will die if their aneurysm ruptures.
The FDA approved the Endurant product after Medtronic conducted a 150-patient clinical trial at 26 medical centers in the United States. the company said there were no post-implant aneurysm ruptures or aneurysm-related deaths in study subjects, nor were there complications related to leaks or device migration.
The Endurant device, which received European regulatory approval in 2008, will compete against products made by Cook Medical, Gore Medical and Endologix inc.
Janet Moore • 612-673-7752