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Endologix Announces Publication Of Powerlink XL Clinical Trial Results

June 11, 2017

Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced the online publication of results from the pivotal prospective, multicenter clinical trial of the Company's Powerlink XL((R)) System for treatment of abdominal aortic aneurysm in large diameter proximal aortic necks. This publication follows the U.S. Food and Drug Administration (FDA) approval in October 2008 of the device and treatment algorithm as a safe and effective endovascular option in patients with infrarenal aortic necks up to 32 millimeters in diameter. The trial showed aneurysm exclusion in 100% of patients at the pivotal one-year follow-up timepoint, with no conversions to open surgical repair, no ruptures and no device migrations. In addition, core lab evaluations of one-year follow up results show 96% of patients had reduced or stable aneurysm sac diameters and there were no aneurysm related mortalities, no stent fractures or limb occlusions, and no Type III or Type IV endoleaks.

William D. Jordan Jr., MD, Chief of Vascular Surgery at University of Alabama at Birmingham, and study investigator in the Powerlink XL trial, said, "There is mounting clinical evidence demonstrating the significant benefits of anatomical fixation in the treatment of AAA, including the results from this study, which shows Powerlink XL's ability to effectively treat patients with large aortic necks. These results are particularly remarkable considering that 85% of the patients in the trial had challenging infrarenal aortic neck anatomies, such as severe thrombus and/or reverse taper, which are considered to be among the most difficult to treat during endovascular repair."

The study, which is titled "Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: Results of a prospective, multicenter trial," was published online on the Web site of the Journal of Vascular Surgery (JVS) and will published in an upcoming issue of JVS. The study was authored by William D. Jordan Jr., MD, William M. Moore, Jr., MD, Jim G. Melton, DO, O. William Brown, MD, JD, and Jeffrey P. Carpenter, MD. The 78-patient study was conducted at 13 centers across the United States according to FDA regulations and guidelines. The trial was designed to study the safety and effectiveness of the Endologix Powerlink XL device in the treatment of patients with large aortic necks up to 32 millimeters in diameter. This is the first FDA study to evaluate the effectiveness of the placement of the Powerlink single-piece bifurcated device on the native aortic bifurcation (anatomical fixation) together with the Powerlink XL proximal extension.

John McDermott, Endologix President and Chief Executive Officer, said, "We are very pleased to announce the publication of exceptional results from our Powerlink XL clinical trial, expanding the clinical evidence supporting the broad use of our products in patients with AAA. We believe these clinical outcomes utilizing Powerlink XL in difficult to treat patients will help increase our share of the large neck AAA market and also contribute to the transition of patients from open surgical to endovascular AAA repair."

Mr. McDermott concluded, "The successful outcomes achieved in the trial mirror what we have been seeing in the field as we leverage successful outcomes with Powerlink XL to introduce surgeons to our products and gain more of their everyday business. Adoption of Powerlink XL is also benefitting from the recent launch of the IntuiTrak Express Delivery System, which simplifies the procedure and is the lowest profile delivery system in the United States to treat AAA patients with aortic necks greater than 28 millimeters."

About Journal of Vascular Surgery

Journal of Vascular Surgery provides vascular, cardiothoracic, and general surgeons with the most recent information in vascular surgery. Original, peer-reviewed articles cover clinical and experimental studies, noninvasive diagnostic techniques, processes and vascular substitutes, microvascular surgical techniques, angiography, and endovascular management. Special issues publish papers presented at the annual meeting of the Journal's sponsoring society, the Society for Vascular Surgery. Journal of Vascular Surgery ranks in the top 5% of the 5,684 scientific journals most frequently cited (2000 Science Citation Index).

About Endologix, Inc.

Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's flagship product is the Powerlink(R) 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.

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 XL Infrarenal Proximal Extension 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, 2008, 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