Endologix Announces Publication of Consolidated Long-Term Anatomical Fixation Clinical Trial Results

IRVINE, Calif., April 28 /PRNewswire-FirstCall/ -- Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today the publication of consolidated results from its prospective, multicenter clinical trials of the Company's Powerlink® stent graft for the endovascular repair of abdominal aortic aneurysms (AAA) using an anatomical fixation technique. The trial results demonstrate no aneurysm ruptures, no conversions to open repair, no device migrations, no stent fractures, no graft fatigue, no junctional endoleaks, no transgraft endoleaks, and 100% freedom from aneurysm-related mortality for up to five years post-implant. In addition, core lab evaluations found a low rate of limb occlusion (0.6% of limbs), with significantly reduced or stable aneurysm sacs in 95% and 93% of patients at one year and five years, respectively.

Lead author of the publication, Jeffrey P. Carpenter, M.D., Professor and Chief, Department of Surgery, UMDNJ-Robert Wood Johnson Medical School, Camden, stated, "The current and consolidated results of the anatomical fixation technique using the Powerlink system for the treatment of AAA provides further compelling evidence to clinically validate this treatment modality. The long-term results of the study, which include no device failures and significant reductions in aneurysm sac volume, compare favorably with existing clinical data using proximal fixation devices. The results are particularly positive considering that 83% of trial patients had hostile aortic neck anatomies, which can increase the risk that the procedure will fail. Moreover, given the known prevalence of peripheral arterial disease in AAA patients, preservation of the aortic bifurcation for future peripheral interventions is a clinically significant benefit of anatomical fixation compared with proximal fixation."

The study, which is titled "Contemporary Results of Endovascular Repair of Abdominal Aortic Aneurysms: Effect of Anatomical Fixation on Outcomes" was published in the April 2010 edition of the Journal of Endovascular Therapy (www.jevt.org). The study was co-authored by a group of multidisciplinary investigators from the Company's Powerlink clinical trials, including Jeffrey P. Carpenter, MD; Mark J. Garcia, MD; Stuart A. Harlin, MD; William D. Jordan, Jr., MD; Matthew T. Jung, MD; Zvonimir Krajcer, MD; and Julio A. Rodriguez-Lopez, MD. The study presents consolidated results from two previously published Powerlink studies and one additional Powerlink study that has been submitted for publication.

The study reports the initial, mid-term, and available long-term results for 157 patients treated with the Powerlink system at 28 centers across the United States according to FDA regulations and approved protocols. All patients received the Powerlink infrarenal bifurcated stent graft via the anatomical fixation technique, with concomitant proximal sealing achieved with a Powerlink aortic extension as dictated by patient anatomical needs.  

Anatomical fixation with Endologix's Powerlink system was developed by the Company in conjunction with early physician users.  The technique leverages the unique unibody design of the Powerlink device and the foundational support of the patient's own aortoiliac bifurcation to naturally inhibit device migration, which is a recognized failure mode of endovascular devices, including proximal fixation stent graft systems that are traditionally placed at the renal arteries.  In addition, Powerlink's unibody design and fixation via anatomical fixation at the patient's aortoiliac bifurcation closely mimics the patient's original anatomy.  This makes it possible for Powerlink patients to undergo future procedures for peripheral arterial disease, which requires arterial access from the opposite femoral artery, crossing through the stent graft.  This type of access is not recommended, and in many patients is not possible, after AAA repair using a proximal fixation device.

John McDermott, President and Chief Executive Officer said, "We applaud the publication authors and all of the trial physicians on their achievement. It is a high priority for the Company to continue to collaborate with the medical community to provide evidence-based clinical data to practitioners treating AAA to help them achieve the best possible outcomes for their patients. These results continue to reinforce the patient-centered benefits of Powerlink stent graft implantation using an anatomical fixation technique, particularly for patients with hostile aortic neck anatomies. We believe these comprehensive outcomes will support increased adoption of endovascular repair in general, and more specifically, of the Powerlink System."

About The Journal of Endovascular Therapy

Journal of Endovascular Therapy, an official publication of the International Society of Endovascular Specialists, publishes peer-reviewed articles of interest to clinicians and researchers in the field of endovascular interventions. The Journal's scope is multidisciplinary, representing all topics related to minimally invasive peripheral vascular diagnosis and treatment. Original clinical studies, experimental investigations, state-of-the-art reviews, rapid communications, case reports, technical notes, editorials and letters to the editor are published, as well as feature articles on the basics of endovascular interventions.

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, specifically including expected physician acceptance of the Endologix 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. 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.

SOURCE Endologix, Inc.