The world is one step closer to a dialysis device that can be readily carried by a patient, while another company is working to create an ultra-thin blood filter for a wearable dialysis device.
The US FDA has granted a Breakthrough Device designation to AWAK Technologies (Singapore) for a new peritoneal dialysis (PD) device, the AWAK PD.
The device is a wearable, portable PD system that incorporates AWAK’s sorbent technology. It weighs less than 2 kg, and 6 to 8 hours of therapy provide 12–16 L of total dialysate flow. The machine is small enough that it may be carried and operated in many different sites, obviating the need for a patient to report to a clinic to connect to a conventional dialysis machine or to dialyze at home. This feature will allow dialysis to be performed as a person moves through a typical day, “on-the-go,” the company states.
The FDA’s Breakthrough Device Designation is granted to expedite the development and review of devices that possibly could provide a more effective treatment or diagnosis for life-threatening or debilitating diseases. To be ruled a breakthrough device, the device must be for a condition with no FDA-approved alternative treatments or must offer significant advantages over the existing approved alternatives.
AWAK earned the FDA designation after the agency reviewed results from the first-in-human safety trial of the AWAK PD. The device was shown “to efficiently remove the accumulation of toxins from the body, and patients in the trial did not experience any serious adverse events during dialysis with AWAK PD,” a company release stated.
A different group of engineers is tackling a portable dialysis material with its design of a blood filtration material just a few atoms thick.
The new material, called MXene, absorbs urea from blood plasma. The engineering group is led by Drexel University’s Yury Gogotsi, PhD. “This material has shown a better ability to adsorb urea molecules from the blood plasma compared to other known sorbents,” Gogotsi said. “This means it could one day make the wearable kidney a reality, improving quality of life for many people.”
A study published in ACS Nano showed that three currently available MXene materials can remove 99% of urea from an aqueous urea solution and 94% from dialysate fluid.
Meng F, et al. MXene sorbents for removal of urea from dialysate: A step toward the wearable artificial kidney. ACS Nano 2018; 12:10518–10528;DOI: 10.1021/acsnano.8b06494