ELGX Endologix Inc

Endologix, Inc. (NASDAQ:ELGX), the developer and manufacturer of the Powerlink� System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), today announced that results from its Powerlink XL� prospective, multi-center clinical trial met the primary endpoint of one-year post-procedure freedom from Type I proximal endoleak. Additionally, no stent graft distal migration was observed in any study patient at one year following the procedure. The trial was conducted under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA) and the Powerlink XL is currently being commercially launched in the U.S. Additional one-year follow-up results for the Powerlink XL study include: 0% aneurysm-related mortality; 0% aneurysm rupture; 0% conversion to open repair; Independent Core Lab evaluation reported no ePTFE graft disruptions, stent fractures, or Type III or IV endoleak; and Stable or significantly reduced aneurysm sac diameter in 96% of patients. Data from the Powerlink XL trial were presented today at the 35th Annual VEITHsymposium� by the trial�s principal investigator Professor William D. Jordan, Jr., MD (Chief of Vascular Surgery, UAB Hospital, Birmingham, Alabama). Dr. Jordan reviewed results of this novel approach to endovascular treatment of patients with aortic necks up to 32 millimeters in diameter. All patients received the Powerlink bifurcated device via anatomical fixation at the aortic bifurcation, as well as the Powerlink XL proximal extension to achieve proximal seal. �These impressive data are consistent with the positive results reported by other clinicians who have used the Powerlink System to treat patients with aortic necks up to 26 millimeters,� stated Dr. Jordan. �Importantly, for the first time, we were able to demonstrate in a designed study the benefit of an AAA endograft in achieving secure fixation at the bifurcation with proximal seal in a patient group with large aortic necks. �These results are even more significant given the relatively high prevalence of hostile neck anatomy with severe thrombus and/or a reverse taper, which occurred in more than 80% of patients. Furthermore, the features of the low-profile catheter with only a single incision site offer the potential for the minimally invasive treatment of patients with limited or difficult access. These patients might otherwise have faced treatment through a highly invasive surgical alternative," added Dr. Jordan. Endologix President and CEO John McDermott said, �One-year follow-up data from this trial indicate that the Powerlink XL is producing outstanding clinical outcomes, which we attribute to our proprietary device design. With the recent FDA approval, Endologix can now address the approximately 15% of endovascular AAA procedures that are performed in patients with aortic necks greater than 26 millimeters, representing an annual $70-million U.S. market opportunity. We are grateful to the study investigators for their active, ongoing participation and expertise in identifying further opportunities for expanded treatment of patients with aortic disease.� About the VEITHsymposium Now in its fourth decade, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The five-day event features�rapid-fire presentations from�world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. VEITHsymposium is sponsored by Cleveland Clinic, Cleveland, Ohio. For additional information contact Pauline T. Mayer, 631.979.3780 or ptm@ptmhcm.com About Endologix Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix's Powerlink System is an endoluminal stent graft for treating 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. Except for historical information contained herein, this news release contains forward-looking statements relating to the introduction of new products and continuing clinical results obtained with the Powerlink System, 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. 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, 2007, 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.