Navigation Links
NxStage Announces CE Mark Approval for Nocturnal Home Hemodialysis
Date:2/19/2013

LAWRENCE, Mass., Feb. 19, 2013 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced CE Mark approval for nocturnal home hemodialysis with the NxStage System One™.  With CE Mark approval, the NxStage System One is continuing its leadership in home hemodialysis technology. NxStage expects to begin marketing the System One for nocturnal dialysis in countries that recognize the CE Mark approval process in the second half of 2013.

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

Nocturnal dialysis, performed while the patient is sleeping, usually between three and five nights per week, allows much greater time on dialysis without additional inconvenience to the patient or their family. Dialyzing while sleeping has many benefits, but also unique risks; NxStage's nocturnal indication shows the Company's leadership in safety and ease of use by minimizing those risks to the satisfaction of regulators.

"This is an important milestone for NxStage as it provides another example of our leadership in home hemodialysis," said Jeffrey Burbank , Chief Executive Officer, NxStage Medical, Inc.  "This approval gives us the unique ability to offer patients and nephrologists greater therapeutic flexibility and an expanded paradigm for dialysis treatment with the System One."

About the NxStage System One
The NxStage System One is the first and only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration (FDA). Its simplicity and revolutionary size (just over a foot tall) provide convenient use in patients' homes and give patients the freedom to travel with their therapy.   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, at home or on the road. 

The NxStage System One is not specifically cleared in the US for nocturnal home hemodialysis. The Company is currently in a trial to support this indication.

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 the Quarterly Report on Form 10-Q for the quarter ended September 30, 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.


'/>"/>
SOURCE NxStage Medical, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Shows NxStage Daily Home Hemodialysis Patients More Likely to Receive Kidney Transplant
2. Former NxStage Patient Nikolas Gieske Celebrates Kidney Transplant
3. FREEDOM Study Data: Patients Experience Sustained Quality of Life Benefits with More Frequent Home Hemodialysis with the NxStage System One
4. NxStage Reports Record Revenue For The Second Quarter Of Fiscal 2012
5. NxStage to Present at the Canaccord Genuity 32nd Annual Growth Conference
6. NxStage Patient and Advocate Brian Hess Receives Prestigious Honor from American Association of Kidney Patients
7. NxStage Submits Formal Comments to CMS to Improve Patient Access to Life-changing More Frequent Home Hemodialysis Therapy
8. NxStage Names Todd M. Snell Senior Vice President of Quality Assurance, Regulatory & Clinical Affairs
9. NxStage Reports Record Revenue for the Third Quarter of Fiscal 2012
10. NxStage Announces Fourth Quarter 2012 Investor Conference Schedule
11. Robert Funari Joins NxStage Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... 2016 Australia Glaucoma Surgery Devices Market ... report, "Australia Glaucoma Surgery Devices Market Outlook to ... Glaucoma Surgery Devices market. The report provides value, ... and average prices (USD) within market segement - ... company shares and distribution shares data for each ...
(Date:12/8/2016)... 8, 2016 Global Interventional Radiology Market: ... global interventional radiology market analyzes the current and ... an elaborate executive summary, including a market snapshot ... sub-segments. The research is a combination of ... bulk of our research efforts along with information ...
(Date:12/8/2016)... 8, 2016  Diplomat Pharmacy, Inc. (NYSE: DPLO) has been recognized ... Top Workplaces National Standard. To learn more about ... ... Inc.) ... survey administered by WorkplaceDynamics, LLC, a research firm specializing in organizational ...
Breaking Medicine Technology:
(Date:12/9/2016)... ... December 09, 2016 , ... The Pennsylvania Athletic Trainers’ ... during the summer of 2016. The program was made possible by a Pennsylvania ... Department of Health and Human Services Administration. The broadcast, Use Your Head: ...
(Date:12/8/2016)... ... December 08, 2016 , ... Russ DiGilio ... the first national #QuackGivesBack campaign which supported local breast cancer organizations during National ... Quack Gives Back initiative, and we’re very pleased with the participation ...
(Date:12/8/2016)... ... December 08, 2016 , ... CURE Media Group, the ... advocacy groups, has aligned with Upstage Lung Cancer in efforts to combat lung cancer, ... Michael J. Hennessy, Jr said, “CURE Media Group is honored to team up with ...
(Date:12/8/2016)... Fla (PRWEB) , ... December 08, 2016 , ... ... smarter modes of access for customers and employees that are both engaging and ... 7 with Service Smart Technology, the software company revealed today its plans to ...
(Date:12/8/2016)... ... December 08, 2016 , ... STAT courier is pleased to announce ... service for Texas, they are expanding their presence in Dallas. One of the most ... will bring new jobs to the Dallas and Forth Worth market. STAT takes pride ...
Breaking Medicine News(10 mins):