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:9/12/2017)... , Sept. 12, 2017   EcoVadis , the leading platform for ... the first annual edition of its Global CSR Risk and Performance Index. ... by EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 data points ... ... ...
(Date:9/9/2017)... , Sept. 9, 2017  Eli Lilly and ... primary and secondary endpoint data for lasmiditan, an investigational, ... which demonstrated statistically significant improvements compared to placebo in ... highlighted today at the 18th Congress of the International ... "The data presented today demonstrate lasmiditan,s potential ...
(Date:9/7/2017)... WARSAW, Ind. , Sept. 7, 2017  Zimmer ... leader in musculoskeletal healthcare, today announced that it will ... Annual Global Healthcare Conference at the Grand Hyatt hotel ... September 11, 2017 at 11:40 a.m. Eastern Time. ... accessed via Zimmer Biomet,s Investor Relations website at ...
Breaking Medicine Technology:
(Date:9/22/2017)... ... ... “Letters From Home”: a moving compilation of letters that remind readers of ... Home” is the creation of published author, John Allred, a passionate leader of ministry ... International, who has traveled and ministered on four continents. , “It is my hope ...
(Date:9/21/2017)... CA (PRWEB) , ... September 21, 2017 , ... With ... so fun and easy to do. Users can select from up to two layers ... with a click of a mouse all within Final Cut Pro X. ...
(Date:9/21/2017)... ... September 21, 2017 , ... The American Addiction Treatment ... for professionals in the addiction treatment industry entitled: Special Investigations Unit (SIU) ... companies and state and federal governments are increasingly scrutinizing the addiction treatment industry ...
(Date:9/21/2017)... ... ... Bill Howe Plumbing’s mission is to create an employee friendly company, provide ... over 37 years, they have operated with their mission at the foundation and have ... They were chosen as the Best San Diego plumber in 2016, named a Top ...
(Date:9/21/2017)... , ... September 21, 2017 , ... ... developing low-cost and highly accurate cancer screening tests, has received two prestigious recognitions ... in cancer survival rates. , Preora has been named a Top ...
Breaking Medicine News(10 mins):