LAWRENCE, Mass. —
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.
Press release via NxStage Medical.