Five-year data demonstrates safe and effectiveness of AneuRx system.
Medtronic has released the fourth edition of the AneuRx Clinical Update. The Update includes newly-released longterm data from the AneuRx IDE Clinical Trial, a study which included 1,193 patients treated with an early generation of the AneuRx device. According to the company, this represents the largest collection of clinical data available for any commercially approved endograft, including more than 1,000 patients in its clinical trial and 70,000 implants since 1996. The Clinical Update is availble online at www.medtronic.com/physician/ AneuRx. Of more than 600 patients in the trial at five years of follow-up, 96% were free from an aneurysm-related death. In collaboration with FDA, Medtronic also analyzed aneurysm-related death using a broader FDA definition, and the analysis showed a freedom from aneurysmrelated death at five years of 94.6%. Between four and five years of follow-up, there was an observed increase in aneurysm-related death. Factors that were associated with late aneurysmrelated death include, but are not limited to, poor follow-up, patients refusing treatment, and an elderly patient population. These data show the continued safety and efficacy of this device, taking into consideration early generation endograft designs, the physician learning curve for implantation technique, and liberal patient selection criteria.
In addition to the updated IDE clinical trial results, Medtronic also reports on the AneuRx Post-Market Surveillance Registry and the Lifeline Registry of Endovascular Aneurysm Repair, both of which provide contemporary, real-world usage data on the AneuRx stent graft. In the Post-Market Surveillance Registry, 99% of patients experienced freedom from aneurysm rupture three years, 96% of patients experienced freedom from surgical conversion at three years. The incidence of migration in both registries consisted of a single report of migration out of a patient cohort of 334, representing a migration rate of 0.3% at three years. Several other key areas highlighted in the Clinical Update include information on endoleaks, migration, and the related importance of appropriate patient follow-up. As with all devices used in endovascular aneurysm repair, patient follow-up compliance is critical for successful long-term outcomes. “This report provides vascular surgeons with an in-depth analysis of the long-term safety and efficacy data on the AneuRx Stent Graft,” said Dr Rodney White, Vascular Surgery Division Chief, Harbor-UCLA Medical Center.