Clinical Data Showing Superior Results For Vasca's LifeSite Hemodialysis Access System to be Presented at Annual Meeting of the American Society of Nephrology.Business/Technology Editors and Health/Medical Writers TEWKSBURY, Mass.--(BW HealthWire)--July 25, 2002 Vasca, Inc., the developer, manufacturer and marketer of the LifeSite(R) Hemodialysis Access System, announced today that two abstracts showing superior results with the LifeSite Hemodialysis Access System compared to a standard hemodialysis catheter have been accepted for presentation during the upcoming annual meeting of the American Society of Nephrology nephrology Branch of medicine dealing with kidney function and diseases. An understanding of kidney physiology is important not only in treating kidney disease but in knowing the effect of drugs, diet, and hypertension on kidney disease, and vice versa. in November. The data to be presented are based on the results of an ongoing clinical trial with the LifeSite System. The first abstract reports that the one-year device survival rate for patients using the LifeSite System was significantly higher than the device survival rate for patients utilizing a standard hemodialysis catheter for the same observation period. The patients utilizing the standard hemodialysis catheter were more than twice as likely to require non-planned device removal during the first year after implant than patients with LifeSite System. Device removal usually resulted either from infection or device-related malfunction mal·func·tion v. 1. To fail to function. 2. To function improperly. n. 1. Failure to function. 2. Faulty or abnormal functioning. . Using standard analytical methods, the estimated one year device survival rate for the LifeSite System was 67 percent compared to 48 percent for the standard hemodialysis catheter. Device survival curves were censored cen·sor n. 1. A person authorized to examine books, films, or other material and to remove or suppress what is considered morally, politically, or otherwise objectionable. 2. for planned removals such as bridges to permanent access and transplants as well as for non-device related deaths. A second abstract based on the results from the study reports that the use of the LifeSite System was associated with a lower device-related infection rate when compared to the use of a standard hemodialysis catheter. The risk of device-related infection was significantly lower for high-risk patients who had diabetic end-stage renal disease End-stage renal disease (ESRD) Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity. Mentioned in: Chronic Kidney Failure end-stage renal disease or a history of prior vascular access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing . "The use of hemodialysis catheters is associated with a significant increase in the rate of infections and bacteremia bacteremia: see septicemia. bacteremia Presence of bacteria in the blood. Short-term bacteremia follows dental or surgical procedures, especially if local infection or very high-risk surgery releases bacteria from isolated sites. compared to other access options " stated Steven Schwab, M.D. from Duke University and a member of the LifeSite Hemodialysis Study Group." The data from this study shows the LifeSite System may reduce the substantial morbidity associated with venous hemodialysis access and improve patient outcomes". Vascular access complications remain one of the largest causes of morbidity in the hemodialysis population and are a leading cause of hospitalization hospitalization /hos·pi·tal·iza·tion/ (hos?pi-t'l-i-za´shun) 1. the placing of a patient in a hospital for treatment. 2. the term of confinement in a hospital. for these patients. "The positive clinical results from this trial continue to validate the LifeSite System as a safe and effective hemodialysis vascular access option," said Tom Glover, President and Chief Executive Officer of Vasca, Inc. The LifeSite Hemodialysis Access System is the first totally subcutaneous hemodialysis access system commercially available to patients in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Over 4,500 patients have utilized the LifeSite System for hemodialysis access in the United States since it received 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. 510(k) Clearance in August 2000. The LifeSite System is designed to provide for high-flow vascular access, a low rate of thrombosis, and a low rate of infection in patients requiring hemodialysis access while waiting for the creation and/or maturation of permanent hemodialysis access. The LifeSite System also allows for immediate post implantation use and flexibility of placement depending on individual patient needs. An additional benefit to patients is the use of the "buttonhole but·ton·hole n. 1. A short straight surgical cut made through the wall of a cavity or canal. 2. The contraction of an orifice down to a narrow slit, as in mitral stenosis. " technique to access the LifeSite(R) valve, which allows for virtually pain free dialysis. About the Company: Vasca, Inc., founded in 1996, is focused on becoming the worldwide leader in Body Access Management by developing innovative access technologies that improve the quality of patient care. The company's LifeSite Dialysis Access System is commercially available in the United States and Canada as well as the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . For more information on Vasca, Inc. and the LifeSite(R)System visit the company website at www.vasca.com |
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