One-Year Data Presented for Medtronic's Endurant AAA Stent Graft

November 10, 2010—Medtronic, Inc. (Minneapolis, MN) announced results for its Endurant stent graft system for the treatment of abdominal aortic aneurysms. One-year patient follow-up data in the United States pivotal study of the device were presented at the VEITH symposium in New York City.

According to Medtronic, the prospective study involved 150 patients at 26 medical centers in the United States and met its primary endpoints. In the study, the Endurant system was associated with no postoperative aneurysm ruptures or aneurysm-related mortalities at 1 year, and there were no mortalities from any cause at 30 days.

The study's primary safety and effectiveness endpoints were major adverse events at 30 days and a composite of technical and treatment success of the device at 1 year, respectively. The study included patients with “landing zones,” or healthy aortic neck lengths, as short as 10 mm, whereas most other trials of aortic stent grafts have required neck lengths of at least 15 mm, the company noted.

The study monitored changes in aneurysm size and stent graft migration. Approximately half (47.1%) of the aneurysm sacs that were treated with the Endurant stent graft system in the study decreased in size between 1 month and 1 year postprocedure, and none of the sacs increased in size; the other 52.9% remained stable in size during the same time period. In addition, none of the stent grafts migrated from their original placement. The study also monitored the occurrence and type of endoleaks and found that there were no type I or III endoleaks through 1 year postimplant.

“The clinical results with Medtronic's Endurant stent graft system out to 1 year in this study are quite encouraging,” commented Michel Makaroun, MD, the study's principal investigator. “Based on this data, the Endurant stent graft, with its low-profile delivery system and accurate deployment, appears to be safe and effective in the short term. It will prove to be a great addition to the currently available devices in the management of abdominal aortic aneurysms for a wide range of patients.

The Endurant stent graft system received CE Mark approval in July 2008. In the United States, it is an investigational device limited to studies approved by the US Food and Drug Administration (FDA). It is currently under review by the FDA for premarket approval. The study was conducted under an FDA investigational device exemption, Medtronic stated.