NxStage to Present Abstract on Home Nocturnal Therapy with System One at NKF 2015 Spring Clinical Meeting
Study shows favorable outcomes for patients performing overnight therapy at home with the System One
LAWRENCE, Mass., March 16, 2015 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of dialysis products, today announced a late breaking abstract, "Home Nocturnal Hemodialysis with Low Dialysate Volume: A Cross-Over Study," outlining favorable outcomes for more frequent home hemodialysis patients who transitioned to home nocturnal hemodialysis with the NxStage® System One™. The National Kidney Foundation accepted the abstract for poster presentation during its 2015 Spring Clinical Meeting in Dallas, Texas.
Results from this study, conducted by nephrologists Brigitte Schiller, M.D. and Brent W. Miller, M.D., supported the Food and Drug Administration's (FDA) recent clearance of the NxStage System One to perform therapy overnight while patients are at home sleeping, known commonly as nocturnal therapy. The Company's System One is the first and only hemodialysis machine cleared by the FDA for this indication.
"This study demonstrates that at-home, overnight hemodialysis is both safe and effective for ESRD patients, and can help them live a full life," said Brigitte Schiller, M.D., Chief Medical Officer of Satellite Healthcare and Principal Investigator of NxStage's home nocturnal hemodialysis trial. "Now that the FDA has cleared the NxStage System One for nocturnal therapy, I am even more committed to furthering the conversation on nocturnal therapy and the incredible benefits it can offer to our patients' health and quality of life."
This poster presentation will take place on Thursday, March 26, 2015 from 6:00 -7:30pm at the Gaylord Texan, and will remain on display 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
The NxStage System One may be used at night while the patient and care partner are sleeping. Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping. These risks include, but are not limited to, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow or increased treatment time or both, and delayed response to alarms when waking from sleep. Ancillary anticoagulant infusion pumps and fluid leak detection devices may be used to decrease certain risks for home hemodialysis treatments performed at any time, but NxStage requires the use of fluid leak detectors to identify leaks from the vascular access, Cycler and Cartridge when performing nocturnal therapy with the NxStage System One.
About the NxStage System One
The NxStage System One is the first and only truly portable hemodialysis system cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy. When combined with the NxStage PureFlow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, including while they are sleeping - at home or on vacation and at a medically appropriate treatment frequency. http://www.nxstage.com/.
About NxStage Medical
NxStage Medical Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company's website at 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 the Annual Report on Form 10-K for the year ended December 31, 2014. 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.
Media contact:
Kristen K. Sheppard, Esq.
[email protected]
Tel: (978) 332-5923
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SOURCE NxStage Medical Inc.
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