Wearable "artificial kidney" in the United States is expected to go on the market in 2 years
It is reported that the US Food and Drug Administration (FDA) recently announced that it would accelerate the approval of small wearable "artificial kidney". The research institute said that if there is continuous and stable research funding, patients with renal failure are expected to wear this artificial kidney within 2 years.
In 2009, a joint research team consisting of the Sinai Medical Center in Los Angeles and the University of California, Los Angeles School of Medicine launched a prototype wearable artificial kidney (WAK). At the end of 2014, this medical product was approved by FDA and entered the clinical trial stage.
The working principle of WAK is similar to that of the traditional kidney washing machine. It also completes the kidney washing process by removing the metabolic waste and impurities in the patient's blood, and then transporting the purified blood back to the damaged tissues in the body. However, the size of the traditional kidney washing machine is the same as that of the cabinet. Even the most advanced kidney washing machine is as big as the printer, while the current WAK device is only about 9 kg. Researchers are trying to reduce its weight to about 4.5 kg.
Patients wearing WAK need to change the filter once a week and add chemicals every day to purify the filtered water. In addition, the WAK powered by a 9-volt battery can work automatically. Victor Gula, a clinical associate professor from the University of California research team, said that all patients participating in the clinical trial can sleep in WAK, and there should be no problem with shower and other normal activities.
In the clinical trial, 7 patients with end-stage renal disease received WAK 24-hour trial wear test. During this period, WAK filtered the water and salt in the blood at the same rate as the healthy kidneys, and the patients did not feel unwell and had no side effects.
However, this device has an important defect. Due to operation failure, 2 of the 7 patients removed the WAK within 24 hours. After the research team has solved this problem, they will carry out a clinical trial of WAK wearing for one week.
The US FDA announced last month that if WAK is proved to be safe and effective, they will accelerate the approval of its listing. Gula said that if researchers can continue to receive funding for follow-up technology research and development and clinical trials, patients with renal failure can wear WAK within two years.