NxStage Medical’s NxGen Hemodialysis System Gains CE Mark

NxStage Medical, Inc., a medical technology company focused on advancing renal care, has announced that its next generation hemodialysis system has received CE mark approval. This innovative system consists of new features and capabilities, including a new touchscreen user interface and integrated blood pressure monitor designed to enhance ease of use for patients performing home hemodialysis.
 
“Our next generation system was developed with extensive patient and customer feedback and builds on our decade long experience in providing life-changing therapy with the NxStage System One to over 30 thousand patients in their homes around the world,” said Joseph E. Turk, president of NxStage Medical, Inc. “We are very excited to expand our portfolio and begin providing patients with new features and capabilities that are designed to significantly improve their therapy experience.”
 
NxStage’s next generation hemodialysis system is currently under review for 510(k) clearance from the United States Food and Drug Administration.
           
The NxStage System One is the first and only truly portable hemodialysis system cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. 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 on-site on-demand. 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, including while they are sleeping – at home or on vacation and at a medically appropriate treatment frequency. In addition, NxStage’s Nx2me Connected Health platform collects important NxStage System One and patient information for flexible viewing, monitoring and reporting that may improve patient management and patient retention, as well as simplify alternative site care. The System One is also used to provide a range of flexible therapy options in more traditional care settings such as hospitals and dialysis centers. Its safety and performance have been demonstrated by experience with more than 14 million treatments with tens of thousands of patients around the world.