Healthcare Industry News: endoluminal stent graft
News Release - February 12, 2007
Endologix Powerlink System Demonstrates Success in Difficult AAA Anatomies
Powerlink System Highlighted in Three Presentations at the International Congress XX on Endovascular InterventionsIRVINE, Calif.--(HSMN NewsFeed)--Endologix, Inc. (Nasdaq:ELGX ) today announced that favorable data, which includes five-year patient follow-up data from the Company's Powerlink® System pivotal clinical trial, supports the use of the Powerlink device in patients with anatomies considered difficult to treat with traditional endoluminal stent grafts (ELGs). The Powerlink System is being featured in three presentations at the International Congress XX on Endovascular Interventions being held February 11-15, 2007 in Scottsdale, Ariz.
John T. Collins, M.D., from Borgess Medical Center in Kalamazoo, Mich., today will present his abstract, "Secondary Intervention in Unfavorable AAA Neck Anatomy," which includes core lab-reviewed data demonstrating the Powerlink System's ability to effectively treat patients with reverse-tapered neck anatomies. Of the 50 patients in the Powerlink System pivotal clinical trial identified with reverse-tapered aortic necks, no secondary procedures were required for migration or proximal Type I endoleaks through a mean follow-up of 40.2 months (range 1 -- 64 months).
A second presentation scheduled Tuesday, "New Approach to Prevent Distal Migration and Rupture in EVAR: Anatomical Fixation," will feature Professor Dieter Raithel, M.D., Southern Clinic in Nuremberg, Germany. His discussion will highlight data from 378 patients treated over seven years with the Powerlink that demonstrates the long-term efficacy of an implant strategy of anatomical fixation to place the Powerlink stent graft on the aortic bifurcation, which allows for treating anatomies previously unsuitable for endovascular aneurysm repair (EVAR).
On Wednesday, Jeffrey Carpenter, M.D., University of Pennsylvania School of Medicine, in his presentation "Results of EVAR for Small versus Large Aneurysms," will discuss five-year follow-up data from the pivotal study that indicates that patients with larger aneurysms treated with the Powerlink System had no greater incidence of major adverse events, secondary procedures or endoleaks than those with smaller aneurysms. Dr. Carpenter will also note that there were no aneurysm ruptures, no graft material failures and no stent fractures through the five-year follow-up period, demonstrating the excellent durability of the Powerlink System.
On Tuesday, Endologix will host "Ask the Expert Breakfast Session," featuring Professor Raithel presenting his experience in treating more than 378 patients with the Powerlink System.
"These presentations are important as they suggest that design features unique to the Powerlink have positive clinical ramifications," said Paul McCormick, Endologix president and chief executive officer. "Presentations of this positive data at the prestigious International Congress assist in creating awareness of the Powerlink System, our superior design features and exceptional long-term outcomes with physician thought-leaders, which is key in our strategy to drive Powerlink System usage."
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. Additional information can be found on Endologix's Web site at www.endologix.com.
Source: Endologix
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