Healthcare Industry News: abdominal aortic aneurysm
News Release - August 21, 2007
Endologix Completes Enrollment in Powerlink Trial with 34 Millimeter Diameter Infrarenal CuffIRVINE, Calif.--(HSMN NewsFeed)--Endologix, Inc. (Nasdaq: ELGX ) announces that enrollment is complete in its multicenter, nonrandomized, controlled IDE clinical trial that is intended to support U.S. Food and Drug Administration (FDA) approval of the large 34 mm diameter PowerlinkŪ infrarenal cuff in conjunction with the Powerlink bifurcated stent graft system. Patients will continue to be followed to complete the one year primary endpoint analysis, during which time an additional 120 patients may be treated and followed at up to 20 clinical sites under an FDA-approved continued access provision of this protocol.
The Powerlink System is a bifurcated endoluminal stent graft (ELG) approved by the FDA for the minimally invasive treatment of abdominal aortic aneurysm (AAA). In this trial, a 28 mm Powerlink System bifurcated stent graft was utilized with a 34 mm proximal cuff to exclude blood flow from the aneurysm in patients with aortic necks up to 32 mm in diameter.
"Not only are we are establishing a reputation for our Powerlink System as the ELG of choice, but for many patients with unfavorable anatomies we believe our technology may uniquely meet their clinical needs that may not be properly addressed with other available ELGs," said Paul McCormick, Endologix president and chief executive officer. "In addition to the estimated 35,000 ELG procedures to be performed in the U.S. this year, almost an equal number of patients still will be referred for open surgery. We believe the Powerlink is a technology that can improve outcomes as well as expand the role for ELGs for many of these patients."
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. 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, including with respect to continuing clinical trials and regulatory approvals, 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, 2006, 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.
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