Clinical Data Presented at European Congress Indicates Exceptional Results with the Endologix Technology.Business Editors & Health/Medical Writers IRVINE, Calif.--(BW HealthWire)--April 8, 2002 Endologix Inc. today announced that the clinical results of the use of its PowerLink(R) System were presented at the European Vascular Course (EVC) in Amsterdam, The Netherlands. Dr. Patrick Peeters, (Imelda Cardiovascular Center, Bonheiden) reported on a retrospective study of 40 patients from 8 hospitals in Belgium, Germany, France and Italy. The authors classified 14 (35%) of the patients that received a PowerLink unfit for conventional open aneurysm repair. The study reported a 100% acute success rate with no deaths, surgical conversions, or endoleaks upon hospital discharge. Twenty-three patients were available for follow up at two years. Of that group there had been no aneurysm ruptures, no late surgical conversions, no detectable migration of the stent graft, no wire fractures and only two endoleaks, both type I, one of which was treated with an extension cuff. The study showed that intervention free survival at two years was 87% for the PowerLink(R) System. The authors concluded that the PowerLink(R) System uni-body design compared favorably to other devices. Professor Pierre Eduard Magnan (Hopital La Timone, Marseille) presented the results from the French Trial. Sixty-four (64) patients, from 14 French centers were treated with the PowerLink(R) System. This study reported a 100% success rate for device deployment with no deaths or surgical conversions during the perioperative period of one month. At a mean follow-up period of 10.4 months, there were no aneurysm ruptures, surgical conversions or secondary procedures. Two reported deaths were not device related (1 bladder carcinoma and 1 stroke). In addition, the authors reported a 6% post-procedural endoleak rate, all of which were type II requiring no intervention. The authors concluded that the preliminary results for the PowerLink(TM) System are good and that the device carries a low risk for endoleaks compared to reports published for other devices. The results of this study will be presented to the French Regulatory Authority in connection with the submission for approval to begin commercialization of the PowerLink System in France. Endologix is a developer and manufacturer of minimally invasive treatments for vascular diseases. Its first technology is an endoluminal stent graft (ELG ELG - Endoluminal Graft ELG - Engineering Log Generator ELG - Enhanced Landing Gear (US Army Apache helicopter) ELG - European Liaison Group ELG - Executive Level Group ELG - Export-Led Growth), for the treatment of abdominal aortic aneurysms (AAAs). AAA is the 13th leading cause of death in the United States. Analysts estimate that annual sales for ELGs will grow from $500 to $670 million by 2005. On Feb. 11, 2002, Endologix announced it signed a definitive merger agreement with Radiance Medical Systems Inc. (Nasdaq:RADX). |
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