FDA Grants Vasca, Inc. 510k Clearance for Long Term/Chronic Use of the LifeSite Hemodialysis Access System.Business Editors/Health/Medical Writers TEWKSBURY, Mass.--(BUSINESS WIRE)--Jan. 8, 2004 Vasca, Inc., a privately held medical device company, announced today that it has received 510(k) clearance from the 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. ) to market the LifeSite(R) Hemodialysis Access System as a fully implantable blood access device for chronic (long term) hemodialysis. This new long term/chronic indication allows the innovative LifeSite technology to be used in patients who would otherwise be treated with standard cuffed tunneled hemodialysis (HD) catheters. According to Anataole Besarab, M.D., Division 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. and Hypertension, Henry Ford Hospital Henry Ford Hospital is a hospital located in Detroit, Michigan a few blocks from Wayne State University and the New Center area, near the Fisher Building and Cadillac Place. The hospital was founded in 1915 by Henry Ford as a philanthropic project. and Chairman of the National Kidney Foundation's Kidney/Dialysis Outcomes Quality Initiative (K/DOQI K/DOQI Kidney Disease Outcomes Quality Initiative ) 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 Workgroup, "the use of hemodialysis catheters is associated with a significant number of clinical complications including an increased 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. . The LifeSite System is an attractive alternative for both physicians and patients since its use has been shown to be associated with increased blood flow and dialysis adequacy, a lower rate of access-related complications and infections and improved device survival compared to a standard hemodialysis catheter." "We are very pleased that the FDA has given us 510(k) clearance for the long-term, chronic use of the LifeSite System based on their thorough review of our 12 month clinical data associated with the use of this device," stated Bernard E. Lyons, Ph.D., Vasca's President and Chief Executive Officer. "The expansion of our indications for use will allow the device to be used not only as an ideal bridge device for patients awaiting the creation and/or maturation of an AV fistula fistula (fĭs`ch  lə), abnormal, usually ulcerous channellike formation between two internal organs or between an internal organ and the skin. but also for a significant group of patients who are not candidates for peripheral AV access." The number of hemodialysis patients being treated with HD catheters is estimated to be in excess of 100,000 patients. It is estimated that Medicare spends approximately $1.5 billion per year in hemodialysis access related complications. The primary contributor to this huge cost burden is the high rate of complications with HD catheters, in particular, thrombosis, poor flow rates and infection. Lyons added, "With the recent award of a unique CPT CPT See: Carriage Paid To code and increased reimbursement for the outpatient placement of the LifeSite System physicians now can offer their patients another central venous access treatment alternative for chronic 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. For more information on Vasca, Inc. and the LifeSite System visit the company website at: www.vasca.com. |
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