NxStage gets FDA ok for Single Needle Technology

[Dannyboy]

***I know 'single needle' systems are not new, just new to NxStage and their Medisystems subsidiary...still, thought it curious..see pure speculation comment under 'Nocturnal' on this board***

September 16, 2014NxStage Announces FDA Clearance of Single Needle TechnologyInnovative needle design to enhance patient safety[/font]
[/font]
LAWRENCE, Mass., Sept. 16, 2014 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced its single needle technology, OneSite™, has received FDA clearance.
The OneSite employs a unique dual lumen needle design offered in both a sharp version with MasterGuard® and a buttonhole version with SteriPick® allowing the dialysis patient to have only one needle inserted per dialysis treatment instead of two. The combination of single site and buttonhole access is designed to provide patient comfort during needle insertion and dialysis treatment, as well as preservation of the patient's vascular access. The dual lumen design also enhances patient safety during treatment by having the machine alarm and shutdown upon access dislodgement, reducing the risk of undetected Venous Needle Dislodgement (VND) in the use of a two needle treatment.
"FDA clearance 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 safety for our home dialysis patients," said Joseph E. Turk, President, 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). 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. 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 vacation and at a medically appropriate treatment frequency. http://www.nxstage.com/.
About NxStage Medical NxStage Medical, Inc. 
NxStage 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 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.
VP of Investor Relations
ksheppard@nxstage.com
Logo - http://photos.prnewswire.com/prnh/20110503/MM94799LOGO
SOURCE NxStage Medical, Inc.