Endologix Announces TCT 2004 Events; Live Powerlink System Surgical Procedure and Favorable Follow-on Clinical Data Presented.IRVINE, Calif. -- Endologix, Inc. (Nasdaq:ELGX) today announced that a live case demonstration of the Powerlink(R) System for the treatment of an abdominal aortic aneurysm abdominal aortic aneurysm A focal aortic dilation of ≥ 50% ↑ in diameter, accompanied by distension and weakened aortic wall Epidemiology Incidence is rising 12/105–1951; 36/105 (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. ) and favorable follow-up clinical data from the Endologix pivotal trial were presented at Transcatheter Cardiovascular Therapeutics (TCT TCT The Capital Times (Madison, WI newspaper) TCT Transcatheter Cardiovascular Therapeutics TCT The Coroner's Toolkit TCT Trans Canada Trail TCT Tcl Core Team TCT Tsukuba College of Technology (Japan) ) 2004 conference held in Washington, D.C. from September 27 to October 1. During Tuesday's "Live Case Session," a real-time surgical procedure using the Powerlink System to repair an AAA in a patient at the Arizona Heart Institute and Hospital was viewed by TCT conference attendees via satellite. The Powerlink device was successfully deployed during an operation performed on a 66 year old man by Dr. Julio Rodriguez from the Arizona Heart Hospital. During Friday's "Abdominal Aortic aortic pertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. Endografts -- Updates and Next Generation Devices" session, Dr. Jeffrey P. Carpenter, professor of surgery at the University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli. http://upenn.edu/. Address: Philadelphia, PA, USA. , presented follow up data from Endologix's pivotal clinical trial that compared the Powerlink System to conventional surgery. The pivotal trial included 193 test patients and 66 controls treated by conventional surgery. Trial highlights include: --The Powerlink System was successfully deployed in 97.9% of test patients. --Mean length of hospital stay was 3.3 days for Powerlink patients versus 9.5 days for surgical controls patients. --One-third of test patients were treated using regional or local anesthesia Anesthesia, Local Definition Local or regional anesthesia involves the injection or application of an anesthetic drug to a specific area of the body, as opposed to the entire body and brain as occurs during general anesthesia. . --Operative time, blood loss, and ICU ICU intensive care unit. ICU abbr. intensive care unit ICU see intensive care unit. ICU and hospital stays for Powerlink System patients were significantly lower compared with control patients. --The study indicated a significantly lower mortality rate for Powerlink patients versus surgery during the perioperative perioperative /peri·op·er·a·tive/ (-op´er-ah-tiv) pertaining to the period extending from the time of hospitalization for surgery to the time of discharge. per·i·op·er·a·tive adj. period, of 1.04% and 6.06%, respectively, in spite of the mean age of the Powerlink System cohort being significantly older, 73 years versus 70 years. --Significantly fewer major adverse events, such as myocardial infarction myocardial infarction: see under infarction. and renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, were reported during the 30-day perioperative period in the Powerlink System cohort compared with the control group. Dr. Carpenter's presentation, which included results from patients monitored for more than two years following the Powerlink procedure, indicated a low rate of device migration a significant reduction in both aortic sac diameter and volume, and no reported aneurysm aneurysm (ăn`y rĭzəm), localized dilatation of a blood vessel, particularly an artery, or the heart. ruptures, wire fractures, or Type III or IV endoleaks. "The week-long TCT conference proved to be very productive in driving awareness of our Powerlink System and its advantages with physicians and the investment community at a time when we are approaching marketing approval," said Paul McCormick, president and chief executive officer. Endologix has filed a pre-market approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) submission with the U.S. Food and Drug Administration for the Powerlink System and anticipates market approval later this year. About Endologix Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. AAA, a life threatening condition, 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 AAAs is approximately 75%, making it the 13th leading cause of death in the United States. Most patients with an AAA do not exhibit any symptoms and the first sign oftentimes is a rupture of the aneurysm. When an AAA ruptures, patients will experience pain in the abdomen and back, fainting and loss of consciousness frequently leading to shock and death. Once diagnosed, AAA patients will be managed by a combination of medical therapy and non-invasive monitoring, or by undergoing a major surgical procedure to repair the aneurysm. Additional information about Endologix and its products can be found 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 clinical trials and the regulatory approval process, 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, 2003 and the Company's other filings with the U.S. Securities Exchange Commission. |
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