Endologix Announces Publication of Data From PEVAR Randomized Trial

February 18, 2014—Endologix, Inc. (Irvine, CA) announced the publication of data from the first prospective, multicenter, randomized clinical trial of a totally percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR) online ahead of print in the Journal of Vascular Surgery. 

In this article, the investigators report on the randomized trial results comparing PEVAR using the Endologix sheath-based system delivered using a percutaneous approach (ie, the preclose technique) with the Perclose ProGlide suture-mediated closure system (Abbott Vascular, Santa Clara, CA) versus surgical-access EVAR (SEVAR). Peter R. Nelson, MD, MS, Assistant Professor of Vascular Surgery at University of Florida in Gainesville, Florida, is the lead author of this article, as well as the study’s Principal Investigator. 

The investigators state that the trial met its primary endpoint of treatment success by demonstrating the noninferiority of PEVAR to SEVAR (P < .004). The procedural technical success of PEVAR in the multicenter setting was 94%, and the mean procedure time and the time to hemostasis were reduced in the PEVAR arm by 34 minutes (P = .006) and 13 minutes (P = .002), respectively. Additional clinical utility measures with trends favoring PEVAR included reduced anesthesia time, reduced blood loss and need for transfusion, shorter hospital stay, and fewer analgesics prescribed for groin pain.

Based on the PEVAR trial, the US Food and Drug Administration granted expanded labeling for the AFX endovascular AAA system, with a specific indication for PEVAR (including a bilateral percutaneous approach).