Endologix Announces Presentation of Favorable Initial PEVAR Trial Results
IRVINE, Calif., Feb. 15, 2011 /PRNewswire/ -- Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today the presentation of the initial clinical results from the PEVAR Trial at the 2011 iCON (International Congress of Endovascular Specialists) annual meeting in Scottsdale, Arizona. Among 33 patients enrolled in the Roll-In phase of the trial, technical success rates of 97% (access) and 100% (endovascular repair) have been achieved, with no major adverse events observed. Patients were discharged from the hospital at an average of 1.4 days following the procedure.
Participating investigator and presenter Zvonimir Krajcer, MD (Director, Peripheral Vascular Disease Service, St. Luke's Episcopal Hospital at the Texas Heart Institute, Houston, TX) commented, "In our multidisciplinary practice, a totally percutaneous approach to endovascular repair with the IntuiTrak System and Abbott's Prostar XL closure device has demonstrated substantial patient benefits as we recently reported in the Journal of Cardiovascular Surgery. These initial outcomes in the PEVAR Trial roll-in phase are consistent with the published single center data, and have served to support initiation of the randomized phase of the trial. We are very pleased with the initial results, and look forward to completion of the randomized trial very soon."
The PEVAR Trial is the first multicenter, prospective, randomized trial of totally percutaneous endovascular repair of abdominal aortic aneurysm and is being conducted at 20 centers in the United States under an Investigational Device Exemption approved by the U.S. Food and Drug Administration.
John McDermott, President and Chief Executive Officer said, "We applaud the PEVAR Trial investigators for their diligence and dedication to the trial, and commitment to improving patient outcomes. We