The U.S. FDA today approved the Endurant AAA endovascular stent graft system from Medtronic, according to the company’s press release. As we have reported before, this is the company’s next generation endovascular AAA device, especially well suited for complex, tortuous aortas:
The Endurant stent graft is a flexible wire frame (stent) sewn onto a specially woven fabric tube (graft) that physicians use to create a new path for blood flow in the patient’s aorta, reducing pressure on the aneurysm and the risk of rupture. Delivered through catheters inserted into blood vessels in the groin, the new device is designed to conform to a broad range of aortic anatomies, enabling physicians to offer endovascular aortic repair (EVAR) to more AAA patients than ever before.
In the study, which supported the device’s FDA approval, there were no post-implant aneurysm ruptures or aneurysm-related deaths through one year of patient follow-up, and no patients experienced enlargement of their aneurysms (all remained stable or shrank in size) during this timeframe. Also through one year, there were no device migrations or device-related “endoleaks,” which can result in persistent blood flow into the aneurysm sac and enlargement of the aneurysm. The study involved 150 patients and 26 medical centers, and successfully met its primary goals and endpoints for assessing the safety and effectiveness of the Endurant stent graft.
Press release: FDA Approves Medtronic Device to Fix Abdominal Aortic Aneurysms
Product page: Endurant AAA Stent Graft System
Flashback: Endurant Stent Graft System For Tortuous Aortas