Last week we wrote about NxStage® and its new CE approval for its System One dialysis machine. Now the company has announced that its single needle technology, OneSite™, has received CE Mark approval.
NxStage tells us that its System One is the first and only truly portable hemodialysis system cleared for home use by the U.S. 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.
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.”
Source: NxStage, Inc., PR Newswire