Study Shows Safety and Effectiveness for Abdominal Aortic Aneurysm Stent System
November 22, 2010 - An implantable medical device used in the minimally invasive treatment of abdominal aortic aneurysms delivered strong results through one year of patient follow-up in a U.S. pivotal study. The trial data, which was presented at the VEITHsymposium, looked at the Endurant Stent Graft System, by Medtronic.
In the study, the Endurant System was associated with no post-operative aneurysm ruptures or aneurysm-related mortalities at one year, and there were no mortalities from any cause at 30 days.
“The clinical results with Medtronic’s Endurant Stent Graft System out to one year in this study are quite encouraging,” Michel Makaroun, M.D., the study’s principal investigator, professor and chief of vascular surgery for the University of Pittsburgh School of Medicine. “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 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 study monitored changes in aneurysm size and stent graft migration, a concern with current endovascular treatment. Nearly half (47.1 percent) of the aneurysm sacs that were treated with the Endurant Stent Graft System in the study decreased in size between one month and one year post-procedure, and none of the sacs increased in size. The rest (52.9 percent) 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, which can result in persistent blood flow into the aneurysm sac. Through one year post-implant, there were no Type I or III endoleaks.
It received the CE mark in July 2008. The system is an investigational device in the United States.
For more information: www.medtronic.com