2007 Abstracts: Is the Powerlink AAA Stent-Graft Performing as Intended?

Background: The purpose of this analysis was to assess whether or not the Powerlink stent-graft (Endologix, Inc., Irvine, CA) is performing as intended. The Powerlink System was designed to prevent AAA rupture. The current analysis includes all patients in follow up through five years post-implant.
Methods: Between July 2000 and March 2003, 15 sites enrolled 258 patients (192 test patients, 66 control patients) in an IDE multicenter trial of the Powerlink system. Three dimensional reconstructions were produced by the core lab, MMS (Medical Metrx Solutions, West Lebanon, NH) at 1, 6, 12 mos. and annually thereafter.
Results: Technical success and early results have been previously reported. Mean follow-up on test patients is 37.79 months (0-62 months). At five years post-implant, freedom from AAA -related mortality is 97.9%. There have been no aneurysm ruptures. There have been no unusual adverse events at 60 months post-implant. There have been no graft-related infections, graft fabric defects or wire fractures in the study cohort. There have been 33 secondary procedures in 25 patients; 17 of which have been for Type II endoleak. The remaining procedures have been for graft/limb occlusion (7), Type I endoleak (6) and native vessel occlusion (3). There have been no Type III or IV endoleaks in the study group. There have been no secondary procedures due to migration. Aneurysm sac diameters and volumes have been stable or continue to decrease in 96.7% of test patients.
Conclusions: The Powerlink system is safe and provides effective protection from aneurysm rupture through five year follow up. The 5 year data demonstrates protection from AAA sac expansion and the patients are free from rupture. Design and materials of the device continue to demonstrate a strong history of durability.