FDA grants breakthrough designation to wearable dialysis device
- FDA has granted breakthrough device designation to a wearable, portable peritoneal dialysis device made by Singapore-based AWAK Technologies.
- FDA authorized the designation for patients with end-stage renal disease based on results from a first-in-human safety trial of the AWAK Peritoneal Dialysis device completed in October 2018 at Singapore General Hospital.
- The trial showed that the device was able 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 the system, the company said.
End-stage renal disease affects 650,000 patients per year in the United States. Patients must either undergo kidney transplantation or dialysis.
Of the 2.7 million patients on dialysis in 2011, 10.8% of the patients are on peritoneal dialysis and the remaining 89.2% are on hemodialysis, according to AWAK.
In hemodialysis, blood is drawn out of the body and through a synthetic filter called a dialyser. The machine contains two spaces separated by a membrane. Waste products and excess water pass from the blood through the membrane into the fluid through a diffusion process. The fluid containing the waste products is discarded and the clean blood is returned back to the patient's body.
In peritoneal dialysis, the lining of the abdominal cavity acts as the external filter to cleanse the blood. Dialysis fluid is introduced into the abdominal cavity through a tube. The fluid remains in the abdomen for a period of time before it is drained and discarded.
FDA breakthrough device designation is granted to expedite review of technology that demonstrates potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases. The AWAK Peritoneal Dialysis device allows renal patients to avoid long hours of connection to large-size dialysis machines, according to the company.
“The designation reinforces our belief that AWAK PD has the potential to revolutionize the way in which peritoneal dialysis can be delivered and we look forward to collaborating closely with the FDA on the next stages of our development pathway," AWAK Technologies CEO Suresha Venkataraya said in a press release.