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New Data Show Improved Survival, Reduced Cardiovascular Hospital ... - PR Newswire (press release) |
LAWRENCE, Mass., March 25, 2015 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of dialysis products, today announced the presentation of four new abstracts demonstrating clinical outcomes during the National Kidney Foundation's Spring Clinical Meeting in Dallas, Texas. Three of the abstracts highlight improved survival, reduced cardiovascular hospital readmissions, and increased transplantation for daily home hemodialysis (DHHD) patients using the NxStage® System One™ versus other modalities. The fourth abstract details results from the Company's groundbreaking study that led to the clearance of the System One as the first and only hemodialysis machine cleared for home nocturnal hemodialysis (home NHD). The first three abstracts derive from work conducted by Eric Weinhandl, MS, PhD candidate and Dr. Allan Collins of the Chronic Disease Research Group (CDRG), funded by NxStage. These show:
The fourth abstract presented at the meeting, from a NxStage-funded registration trial led by Dr. Brigitte Schiller of Satellite Healthcare and Dr. Brent W. Miller of Washington University in Saint Louis, Missouri, details favorable results of 58 ESRD patients receiving home NHD with the NxStage System One. The study demonstrated results of increased clearance, improved phosphorus control, and comparable safety and efficacy to DHHD. The open-label, prospective, two-treatment, two period crossover, non-inferiority study enrolled, trained, and transitioned DHHD patients to home NHD, and subsequently treated them for eight weeks on home NHD. "These new data continue to highlight the benefits, safety, and efficacy of daily home hemodialysis with respect to important, long intractable challenges not fully addressed by conventional dialysis. The complete alignment of randomized, observational, and epidemiological studies with respect to daily hemodialysis benefits is compelling," said Collins, Director of the Chronic Disease Research Group and Senior Medical Advisor for NxStage. "Moreover, showing that nocturnal hemodialysis may be administered in the home with relative safety and efficacy to gain the first-ever clearance in the U.S. for this indication represents a major milestone in the treatment of kidney disease." "NxStage has long been committed to product innovation and quality clinical research to help improve the lives of patients with kidney failure," said Joe Turk, President of NxStage Medical. "We are delighted that these data will be shared in these important clinical sessions, so that awareness and understanding increase and more patients and their families may ultimately gain access to this life-changing therapy." The posters, numbers 278, 279, 280, and 338, will be presented on Thursday, March 26, 2015 from 6:00 - 7:30pm and remain on display at the Gaylord Texan through Saturday, March 28, 2015. Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed. Additional Risks Associated with Nocturnal Home Hemodialysis Therapy About the NxStage System One About NxStage Medical Forward-Looking Statements Media contact: Logo - http://photos.prnewswire.com/prnh/20110503/MM94799LOGO SOURCE NxStage Medical Inc. RELATED LINKS |