The Wearable Artificial Kidney is a battery-powered hemodialysis machine composed of miniaturized components worn as a tool belt and connected to the patient via catheter, UW Medical said.
The approval came based off the successful results of a 7-patient clinical trial of the device carried out at the UW Medical Center between October 2014 and April 2015, despite technical issues that halted the trial early on, the group said.
“Treatment with the WAK was safe, well-tolerated and effectively cleared patients’ uremic toxins while maintaining electrolyte and fluid balance. These results serve as proof-of-concept that, after the device is redesigned to overcome technical problems, a wearable artificial kidney can be developed as a viable dialysis technology,” Kidney Research Institute director Dr. Jonathan Himmelfarb said in prepared remarks.
Patients wore the device for a 24-hour period, Himmelfarb said. Investigators in the trial said patients equipped with the device “expressed excitement to walk around hospital hallways” while the device was functioning, and that the device functioned “admirably.”
“When patients perform hemodialysis at home, only a few options exist and they are large, heavy and stationary. The WAK represents the first truly portable hemodialysis machine, which could enhance patients’ quality of life and enable them to work and travel as they would otherwise,” study investigator Dr. Matthew Rivara said in a press release.
Because the WAK continuously filters blood, subjects were also temporarily freed from food restrictions associated with salt, potassium and phosphorous, which accumulate in patients undergoing chronic dialysis.
“I was amazed at how well it worked for me. It was heavy and cumbersome, but I’d be wearing it today if I could. It just gives you so much more freedom,” test subject Chuck Lee, who has had diabetes for 40 years and received thrice-weekly dialysis for over 2 years, said in a prepared statement.
Despite eating foods that would normally be restricted, the device reported metabolic and other fluid counts in a healthy range, according to Lee’s wife.
Expedited access pathways grants the group more immediate review from the FDA as they submit material to the agency.
“If we can complete the design expeditiously, they’ll look at it very fast, and even during redesign, they’ll give guidance so we’re not making decisions that compromise our chances to get to the next stage. The WAK showed it could dialyze patients for the full 24 hours, with pretty good results, and that’s a big proof of concept. We have a lot of work to do, but this technology has potential to change quality of life in a big way,” trial co-lead Dr. Larry Kessler said in a press release.