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May 11, 2017

FDA grants clearance to NxStage’s new hemodialysis system

The US Food and Drug Administration (FDA) has granted clearance to NxStage Medical’s System One hemodialysis device.

The US Food and Drug Administration (FDA) has granted clearance to NxStage Medical’s System One hemodialysis device.

Formulated with new features and capabilities, the portable system comes with a touchscreen and integrated blood pressure monitor, allowing ease of use during at-home hemodialysis.

The FDA approval also covers home nocturnal hemodialysis.

NxStage Medical president Joseph Turk said: "Early customer and patient feedback on our next generation system has been very positive in the UK, validating many of the benefits we expected.

"We are very excited to bring these new features and capabilities to the US market, as they are designed to significantly improve our patients' therapy experience.

“The touchscreen interface provides an excellent platform to continue bringing new features and functionality moving forward."

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"The touchscreen interface provides an excellent platform to continue bringing new features and functionality moving forward."

The small size of the device is expected to provide easy at-home use and convenient travel.

It further simplifies the procedure when combined with the NxStagePureFlow SL Dialysis Preparation system, which enables the use of ordinary tap water to create dialysis fluid as and when required.

The data from NxStage System One and patient information can be collected by the firm’s Nx2me Connected Health platform to allow flexible viewing, monitoring and reporting for improved patient management, retention and simple alternative site care.

With confirmed safety and performance via more than 14 million treatments with over 30,000 patients, the system can also be used for various therapies in standard care settings such as hospitals and dialysis centres.


Image: NxStage System One hemodialysis device. Photo: courtesy of PRNewsfoto/NxStage Medical Inc.

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