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 are encouraged by the initial trial results, and look forward to completion of this trial in the near future."
About iCONThe International Congress for Endovascular Specialists annual meeting is presented by the Arizona Heart Foundation and the International Society of Endovascular Specialists. The meeting provides a multidisciplinary forum for the discussion of a wide range of endovascular topics including acute stroke, carotid artery disease, structural heart disease, heart failure therapies, thoracic and abdominal aortic pathologies, and peripheral vascular disorders. There are also concurrent cardiac sessions addressing chronic heart failure, arrhythmias, and percutaneous valve replacement. The meeting is being held from February 13-17, 2011 in Scottsdale, Arizona. More information is available at www.iconmeeting.org.
About Endologix, Inc.Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's flagship product is the Powerlink® System, which is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75%, making it a leading cause of death in the U.S. Additional information can be found on Endologix's Web site at www.endologix.com.
Forward-Looking Statements Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including the success of sales efforts for the Powerlink System and related new products, product research and development efforts, and other economic, business, competitive and regulatory factors. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.COMPANY CONTACT:
INVESTOR CONTACTS:Endologix, Inc.
The Ruth GroupJohn McDermott, CEO
Nick Laudico (646) 536-7030(949) 595-7200
Zack Kubow (646) 536-7020www.endologix.com
|SOURCE Endologix, Inc.|
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