Endologix's Powerlink System Granted Canadian Approval.IRVINE, Calif. -- Endologix, Inc. (Nasdaq:ELGX) today announced that it has been granted approval (Notice of Compliance) on May 27, 2005, by the Canadian Regulatory Agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , Health Canada Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. (HCTPD HCTPD Health Canada Therapeutic Products Directorate (regulatory agency) ) to begin marketing the Company's Powerlink(R) System in Canada. The Powerlink System is an endoluminal stent graft (ELG ELG Early Learning Goals (education) ELG Export-Led Growth ELG Endoluminal Graft ELG Effluent Limitation Guideline ELG European Liaison Group ELG Executive Level Group ELG Engineering Log Generator ) for the minimally invasive treatment of abdominal aortic aneurysms (AAA AAA: see American Automobile Association. (Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied. ). Endologix estimates that there are approximately 400 AAA ELG cases performed annually in Canada. In early 2005, the Company introduced the Powerlink System in the U.S. through a strategic market launch after gaining U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval in late 2004. The Powerlink System is also approved in Europe and is marketed to selected European countries including Belgium, France, Germany and the United Kingdom through a distribution agreement with Edwards LifeSciences AG. "While we have successfully performed a handful of procedures under the special access rules in Canada, we now have full marketing approval and will be evaluating our strategic marketing options in the coming months to introduce the Powerlink in this market," said Paul McCormick, Endologix president and chief executive officer. The Powerlink System is a unibody self-expandable device, with a durable frame made of stainless steel stainless steel: see steel. stainless steel Any of a family of alloy steels usually containing 10–30% chromium. The presence of chromium, together with low carbon content, gives remarkable resistance to corrosion and heat. alloy covered with an ePTFE graft. The one-piece bifurcated bi·fur·cate v. bi·fur·cat·ed, bi·fur·cat·ing, bi·fur·cates v.tr. To divide into two parts or branches. v.intr. To separate into two parts or branches; fork. adj. design featuring a fully supported stent cage was developed to overcome the many shortcomings associated with earlier-generation ELG devices. About Health Canada, Therapeutic Products Directorate (HCTPD) HCTPD is the Canadian medical products regulatory authority. Before medical devices can be legally supplied in Canada, they are subject to rigorous review, and manufacturers are obligated ob·li·gate tr.v. ob·li·gat·ed, ob·li·gat·ing, ob·li·gates 1. To bind, compel, or constrain by a social, legal, or moral tie. See Synonyms at force. 2. To cause to be grateful or indebted; oblige. to provide evidence to establish quality, safety and efficacy of their device, as well as the standard of manufacture of the goods, for review by HCTPD, prior to approval. About Endologix Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix's Powerlink System is an endoluminal stent graft 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 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. |
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