Medtronic has received the US Food and Drug Administration (FDA) approval for the Endurant AAA Stent Graft System, which is used for the minimally invasive treatment of abdominal aortic aneurysm (AAA).
The Endurant stent graft is a flexible wire frame sewn into a specially woven fabric tube, which can be used by the physicians to create a new path for blood flow in the patient’s aorta.
Medtronic said the stent graft, which is delivered through catheters inserted into blood vessels in the groin, is designed to conform to a broad range of aortic anatomies.
The FDA approval was based on a study which successfully met its primary goals and endpoints for evaluating the safety and effectiveness of the Endurant stent graft.
The study involved 150 patients and 26 medical centers, and one year of patient follow-up showed that there were no post-implant aneurysm ruptures or aneurysm-related deaths.
In addition, during this time frame, no patients experienced enlargement of their aneurysms, and there were no device migrations or device-related endoleaks.