Navigation Links
NxStage Announces FDA Clearance for New High Flow Capabilities with NxStage System One
Date:4/30/2013

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.

(Logo:  http://photos.prnewswire.com/prnh/20110503/MM94799LOGO)

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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. NxStage Names Robert G. Funari Chairman Of The Board
2. NxStage Completes Move to Direct Sales In UK
3. NxStage Educational Reception at Annual Dialysis Conference Features Celebrity and Former NxStage User Stephen Furst
4. NxStage Reports Record Fourth Quarter and Full-Year 2012 Financial Results
5. NxStage Announces CE Mark Approval, First Clinical Use of its Single Needle for Dialysis Patients
6. NxStage Announces CE Mark Approval for New High Flow Capabilities with System One
7. NxStage Announces CE Mark Approval for Nocturnal Home Hemodialysis
8. NxStage Initiates 2013 Call to Action Campaign with Launch of Hemodialysis At Home: A Better Way For a Better Life
9. NxStage Home Hemodialysis Patient Awareness Tour Kicks Off January 29th
10. Robert Funari Joins NxStage Board of Directors
11. NxStage Announces Fourth Quarter 2012 Investor Conference Schedule
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... , May 27, 2016 ... the Dario™ Diabetes Management Tool, today announced that the Company,s ... the Marcum MicroCap Conference being held June 1-2 in ... Invitational, being held June 7-9 in Los Angeles, ... will discuss recent corporate and operational milestones, including the U.S. ...
(Date:5/27/2016)... Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), ... Neurology and Orphan Diseases, today announced that President & CEO ... conferences: SeeThru Equity MicroCap Conference   ... City , NY When: Tuesday, May 31 st ... Where: Grand Hyatt Hotel, 109 East 42 nd ...
(Date:5/26/2016)... TARE (Transarterial Radio-embolization) Using ... and Overall Decreased Use of Hospital Resource ... specialist healthcare company, has today announced the publication ... of ISPOR (International Society for Pharmacoeconomics and Outcomes ... using yttrium-90 glass microspheres is associated with cost ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... Georgia State University ... specialty academic programs. , Answering to the increasing demand for curricular specializations, the ... law, and environmental and land use law. ,  , “The demand for lawyers ...
(Date:5/26/2016)... ... May 26, 2016 , ... The Woodlands at John Knox ... new model of care for living and healing, celebrated its grand opening, today. The ... a Real Home provided by Empowered Staff. , “This is an incredibly fulfilling time ...
(Date:5/26/2016)... ... May 26, 2016 , ... MadgeTech will be showcasing its line of ... Warner, New Hampshire at the MadgeTech headquarters. With products sold in more than 100 ... government agencies, including NASA. , In 2012, NASA strategically set up 17 RHTemp101A ...
(Date:5/26/2016)... ... ... An April Gallup survey found rising health care costs to be the top ... Living (SHSL) may not share those same worries thanks to a new bundled ... while holding the line on increasing their contributions, including premiums, deductibles and the portions ...
(Date:5/26/2016)... ... May 26, 2016 , ... Leadership ... solutions, today announced the organization has earned its ISO 13485 certification, indicating the ... compliant with all rules and policies associated with ISO quality standard 13485. ...
Breaking Medicine News(10 mins):