Navigation Links
NxStage Announces CE Mark Approval, First Clinical Use of its Single Needle for Dialysis Patients
Date:2/25/2013

LAWRENCE, Mass., Feb. 25, 2013 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced its single needle technology, OneSite™, has received CE Mark approval. In addition, initial patient experiences using this new product have demonstrated its benefits for dialysis patients.

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

 The OneSite employs a revolutionary dual lumen needle design with a buttonhole approach to cannulation. The combination of single site and buttonhole access greatly reduces the challenges of self cannulation. Having a single site also enhances safety by having the machine alarm upon access dislodgement during treatment, thus helping prevent adverse events associated with Venous Needle Dislodgement (VND).

As the requirement for certain medical devices to be sold in the European Union, this CE Mark approval will enable NxStage to make OneSite available in countries where it currently distributes its products, including the United Kingdom, the Nordic countries, Benelux, France, and Italy. Separately, NxStage has also received approval to market this product in Canada.

"CE Mark approval for OneSite is another significant milestone that illustrates the success of our innovation strategy. It represents a meaningful step forward in advancing the care of dialysis patients and will enhance the success of our recent nocturnal approval for the NxStage System One in Europe," said Jeffrey Burbank , Chief Executive Officer, NxStage Medical, Inc. "Building on our breadth of technology and expertise in fistula needles, we're bringing to market an elegant single needle solution that does not have the complexity and complications of other common approaches."  

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). The System One also has a CE mark and has been cleared by Health Canada. 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. 

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.

CONTACT: NxStage Medical, Inc., ksheppard@nxstage.com


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

Related medicine technology :

1. NxStage Announces CE Mark Approval for New High Flow Capabilities with System One
2. NxStage Announces CE Mark Approval for Nocturnal Home Hemodialysis
3. NxStage Initiates 2013 Call to Action Campaign with Launch of Hemodialysis At Home: A Better Way For a Better Life
4. NxStage Home Hemodialysis Patient Awareness Tour Kicks Off January 29th
5. Robert Funari Joins NxStage Board of Directors
6. NxStage Announces Fourth Quarter 2012 Investor Conference Schedule
7. NxStage Reports Record Revenue for the Third Quarter of Fiscal 2012
8. NxStage Names Todd M. Snell Senior Vice President of Quality Assurance, Regulatory & Clinical Affairs
9. NxStage Submits Formal Comments to CMS to Improve Patient Access to Life-changing More Frequent Home Hemodialysis Therapy
10. NxStage Patient and Advocate Brian Hess Receives Prestigious Honor from American Association of Kidney Patients
11. NxStage to Present at the Canaccord Genuity 32nd Annual Growth Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):