Category Archives: Dialysis Modalities
NxStage Announces FDA Clearance for New High Flow Capabilities with NxStage System One
NxStage Announces FDA Clearance for New High Flow Capabilities with NxStage System One
Product provides patients with benefits of home hemodialysis and greater treatment flexibility based on their clinical and lifestyle needs
LAWRENCE, Mass., April 30, 2013 /PRNewswire/ – NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced that the U.S. Food and Drug Administration (FDA) has cleared new high flow capabilities with the NxStage System One™, the only truly portable hemodialysis system cleared for home use. With this clearance, the Company expects to begin offering its System One with new higher flow capabilities in the United States later this year.
The new higher flow capabilities for the System One enable increased dialysate flow rates, allowing nephrologists expanded possibilities to adjust the duration and frequency of patient prescriptions. Patients can now enjoy the benefits of home hemodialysis and have even greater treatment flexibility based on their clinical and lifestyle needs.
“This latest regulatory milestone reflects strong and systematic execution against our product pipeline,” said Jeffrey Burbank, Chief Executive Officer, NxStage Medical, Inc. “With this new capability, NxStage therapy may be prescribed less frequently, for example 3 times per week or every other day, at treatment times consistent with those that patients and physicians experience in-center today. We’re strong believers in longer and more frequent dialysis for the clinical benefits; still, high flow opens the NxStage solution more broadly to the patient segment that wants the benefits of home, but at in-center frequency.”
NxStage’s high flow capabilities also received CE mark approval in February 2013.
About NxStage Medical Inc.
NxStage is a medical device company, headquartered in Lawrence, MA, USA, which develops, manufactures, and markets innovative systems for the treatment of end-stage renal disease (ESRD), and acute kidney failure. The System One home hemodialysis device developed by NxStage is the only FDA approved portable hemodialysis machine cleared for home use. For more information on NxStage, or NxStage products, visit, http://www.nxstage.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “plan,” and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2012. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Kristen Sheppard
ksheppard@nxstage.com
SOURCE NxStage Medical, Inc.
Marie Benz, MD on Google+NxStage Medical Inc, developer of Home Hemodialysis system, names Robert G. Funari Chairman Of The Board
Robert G. Funari Chairman Of The Board of NxStage Medical Inc.
NxStage Names Robert G. Funari Chairman Of The Board
LAWRENCE, Mass., April 25, 2013 — /PRNewswire/ — NxStage Medical, Inc.® (NASDAQ: NXTM) announced today that Robert G. Funari has been appointed as the non-executive Chairman of the Board effective immediately. Mr. Funari is the former Chairman of Crescent Healthcare and has served on the NxStage Board of Directors since January 2013.
Comparison of the Therapeutic Effectiveness of Sustained Low-Efficiency Dialysis (SLED) with Continuous Blood Purification (CBP) in Critically Ill Patients
Hemodialysis.com Authors’ Interview: Junzhang Cheng
Department of Nephrology, The First Hospital of JingZhou, Yangtze University
Hangkong street 8, Jingzhou 434000, Hubei, China
Hemodialysis.com: What are the main findings of the study?
Answer: Our study addressed that SLED has similar hemodynamic stability with CBP and the two methods have similar treatment effects in critically ill patients. SLED as a viable alternative to traditional CRRT for critically ill patients in whom IHD had previously failed or been withheld.
Aldosterone and Mortality in Hemodialysis Patients: Role of Volume Overload
Hemodialysis.com Author Interview: Dr. Der-Cherng Tarng, MD, PhD
Professor, Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, and Department and Institute of Physiology, National Yang-Ming University, Taipei, Taiwan
Hemodialysis.com: What are the main findings of the study?
Dr. Der-Cherng Tarng: Aldosterone level is inversely associated with adverse outcomes in hemodialysis patients. Volume overload underlies this paradox. In the absence of volume overload, aldosterone is an independent risk factor for all-cause mortality and CV events in this population.
Infection Rates and Associated Pathogens in Patients on Nocturnal Home Hemodialysis Over a Six Year Period
Hemodialysis.com Author Interview: Marisa Battistella, BSc Phm, Pharm D, ACPR
Pharmacy Clinician Scientist
Assistant Professor
Leslie Dan Faculty of Pharmacy, University of Toronto
Clinical Pharmacist-Nephrology
University Health Network
Hemodialysis.com: What are the main findings of the study?
Dr. Battistella: Our study consisted of a 6 year retrospective analysis of the 90 NHD patients.
We evaluated the culture and sensitivity of all samples drawn in NHD patient, prescribed antibiotics and clinical demographic data such as age, gender, race, primary renal disease, comorbidities and duration of dialysis.
High-Efficiency Postdilution On-Line Hemodiafiltration Reduces All-Cause Mortality in Hemodialysis Patients
Hemodialysis.com Author Interview:
Dr. Francisco Maduell
Department of Nephrology and Renal Transplantation
Hospital Clinic, University of Barcelona
Villarroel, 170 – 08036 Barcelona, Spain.
Hemodialysis.com: What are the main findings of the study?
Dr. Maduell: The results of the ESHOL trial indicate that high efficiency postdilution OL-HDF reduces all-cause mortality versus conventional hemodialysis in prevalent patients.
Furthermore, the main causes of mortality, cardiovascular and infectious diseases, were significantly reduced by OL-HDF. The incidence rate of dialysis sessions complicated with hypotension episodes and all-cause hospitalization were lower in patients randomized to OL-HDF
Fresenius Home Hemodialysis Wireless Wet-Detector to be featured at Annual Dialysis Conference
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