Endologix PEVAR Trial Data Presented

January 28, 2013—Endologix, Inc. (Irvine, CA), announced that data from its prospective, multicenter, randomized clinical PEVAR trial  of a totally percutaneous approach (PEVAR) to endovascular abdominal aortic aneurysm repair (EVAR) were recently presented at two medical meetings.

Peter R. Nelson, MD, gave a presentation on the PEVAR trial primary analysis at the 37th annual meeting of the Southern Association for Vascular Surgery, which took place January 23–26, 2013. Dr. Nelson is Assistant Professor of Vascular Surgery at the University of Florida in Gainesville.

Zvonimir Krajcer, MD, presented findings on the closure device in an independent substudy at ISET 2013: the 25th annual International Symposium on Endovascular Therapy, which took place January 19–23. Dr. Krajcer is Program Director of Peripheral Vascular Interventions, Department of Cardiology, St. Luke's Episcopal Hospital at the Texas Heart Institute in Houston.

According to the Endologix press release, Dr. Krajcer and Dr. Nelson reported the randomized trial results comparing PEVAR using the Endologix 21-F (outer diameter) sheath-based system, which was delivered using a percutaneous approach (the 'pre-close' technique) with the Perclose ProGlide suture-mediated closure system (Abbott Vascular, Santa Clara, CA) with surgical access EVAR. The Perclose ProGlide is used in an investigational manner in this US Food and Drug Administration Investigational Device Exemption–approved trial. 

According to the company, the primary trial endpoint was met, definitively demonstrating the noninferiority of PEVAR using the ProGlide closure device to surgical EVAR (P < .0036). There was a 94% procedural technical success rate achieved in a multicenter setting. Mean procedure time was reduced in PEVAR patients by 34 minutes (P = .006). Likewise, mean time to hemostasis following PEVAR was reduced by 13 minutes (P = .002). PEVAR patients required significantly fewer concomitant procedures. Favorable trending of PEVAR in several clinical utility outcomes included reduced anesthesia time, reduced blood loss and need for transfusion, shorter hospital length of stay, and less analgesics prescribed for groin pain. The PEVAR noninferiority to surgical EVAR persisted through the final 6-month follow-up.

According to Endologix, the PEVAR trial was designed to support the safety and effectiveness of the company's 21-F and smaller profile EVAR platforms, including the Powerlink with IntuiTrak system and the AFX endovascular system in the percutaneous treatment of abdominal aortic aneurysm. The company anticipates that the full data from Dr. Nelson's presentation will be published in the Journal of Vascular Surgery during the second quarter of 2013.