FDA accepts protocol for Wearable Artificial Kidney trial- Blood Purification Technologies Inc.
Medical researchers have received approval to begin safety and performance testing of the Wearable Artificial Kidney (WAK). The FDA and the University of Washington Institutional Review Board accepted the protocol for the clinical trial. Expected to start this autumn, 2014, in Seattle, it will be the first human study in the United States to be conducted on the device.
A miniaturized dialysis machine that can be worn as a belt, the WAK concept allows patients with end stage renal failure the freedom to engage in daily activity while undergoing uninterrupted dialysis treatment.
The device was one of three products related to end-stage renal disease that were awarded a special fast-track to market status in April 2012. The program, called Innovation Pathway, is a new system designed to help medical devices reach patients in a safe, timely, and collaborative manner. The Wearable Artificial Kidney is being developed by Blood Purification Technologies Inc. based in Beverly Hills, California.
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