IRVINE, Calif., Jan. 28, 2013 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that data from the first prospective, multicenter, randomized clinical trial of a totally percutaneous approach (PEVAR) to endovascular abdominal aortic aneurysm repair (EVAR) was recently presented at two medical meetings. The presentation on the closure device independent substudy was made by Zvonimir Krajcer, MD (Program Director - Peripheral Vascular Interventions, Department of Cardiology, St. Luke's Episcopal Hospital at the Texas Heart Institute, Houston, TX) at the 25 th Annual International Symposium on Endovascular Therapy (ISET), which took place January 19-23, 2013. The presentation on the PEVAR Trial primary analysis was made by Peter R. Nelson, MD, MS (Assistant Professor of Vascular Surgery at University of Florida, Gainesville, FL) at the 37 th Annual Meeting of the Southern Association for Vascular Surgery (SAVS), which took place January 23-26, 2013.
- The primary trial endpoint was met (P<.0036), definitively demonstrating the non-inferiority of PEVAR using the ProGlide closure device to surgical EVAR
- A 94% procedural technical success rate was achieved in a multicenter setting
- Mean procedure time was reduced in PEVAR patients by 34 minutes (P=.006). Likewise, mean time to hemostasis was reduced following PEVAR by 13 minutes (P=.002)
- PEVAR patients required significantly fewer concomitant procedures
- Favorable trending of PEVAR in several clinical utility outcomes including reduced anesthesia time, reduced blood loss and need for transfusion, shorter hospital length of stay, and less analgesics prescribed for groin pain
- The PEVAR non-inferiority to surgical EVAR persisted through the final 6-month follow-up