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| ![]() | ![]() Endologix Announces First Patients Treated in Powerlink Trial with 34 Millimeter Diameter Infrarenal CuffPress Release October 10, 2005 IRVINE, Calif.--(BUSINESS WIRE)--Oct. 10, 2005--Endologix, Inc. (Nasdaq:ELGX) today announced that the first patients have been treated in the Company's infrarenal clinical trial utilizing a large 34 milli meter diameter cuff with the Powerlink(R) Bifurcated System. The three minimally invasive surgical procedures were performed by Drs. William Moore and Terry Norton. Dr. Moore is Chief of Staff at Lexington Medical Center in West Columbia, S.C. and is board-certified in Vascular and General Surgery. Dr. Norton is the Vice Chief of Surgery at Lexington Medical Center. The Powerlink System is a bifurcated endoluminal stent graft (ELG) approved by the U.S. Food and Drug Administration (FDA) for the minimally invasive treatment of abdominal aortic aneurysm (AAA). These three patients are part of a seven-center, 60-patient trial utilizing a large diameter infrarenal cuff in combination with the Powerlink bifurcated device. "The three patients I treated with the 34 mm cuff along with the Powerlink system were not candidates for currently available minimally invasive stent-graft procedures, and all patients were at high-risk for open surgical repair of the aneurysms. Adding the 34 mm cuff was very straightforward and was easily incorporated into the normal Powerlink procedure. Each of these cases was performed quickly and efficiently without any complications, and the patients were discharged from the hospital within the expected 24 to 48 hours post procedure," said Dr. Moore. "There is a pressing need for this technology as up to 20% of my AAA patients have large diameter aortic necks. I have about a dozen patients currently under evaluation for enrollment in this study, and three are scheduled for this minimally invasive procedure in the coming weeks." Paul McCormick, Endologix president and chief executive officer, commented, "In this clinical trial physicians such as Dr. Moore are utilizing our FDA-approved Powerlink 28 mm device and inserting a large 34 mm cuff at the top to exclude blood flow from the aneurysm sac and treat patients with anatomies that are not amenable to treatment by commercially available ELGs." Endologix also is conducting an ongoing suprarenal clinical trial utilizing the Powerlink 34 mm Bifurcated System, a modification of Endologix's FDA-approved Powerlink System, which is an alternative or potentially complementary technology to treat AAA patients with large diameter aortic necks. If approved for marketing in the United States, the Powerlink would be the only ELG for use in aneurysms with neck diameters up to 32 mm. About Endologix Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix's Powerlink System is an endoluminal stent graft (ELG) 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 the thirteenth leading cause of death in the U.S. In October 2004, Endologix received approval to market the Powerlink 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, the accuracy of which are necessarily subject to risks and uncertainties, including risks related to the clinical trials and regulatory approvals, and payor acceptance of new medical device products, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, all as more fully described in the risk factors and other matters set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2004, and the Company's other filings with the Securities and Exchange Commission. Contacts Endologix, Inc. Paul McCormick, 949-595-7200 www.endologix.com or Investor Contacts: Lippert/Heilshorn & Associates, Inc. Bruce Voss or Jody Cain, 310-691-7100 bvoss@lhai.com jcain@lhai.com www.lhai.com
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