News | February 25, 2013
NxStage Announces CE Mark Approval, First Clinical Use of its Single Needle for Dialysis Patients
Elegant Solution Enhances Company’s Recent Nocturnal Clearance in Europe
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.
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.
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.
NxStage Medical, Inc.