The wearable artificial kidney is completely ready. The Nierstichting is currently preparing clinical trials in France, followed by tests in the Netherlands.
This reports the Nierstichting in an update on the wearable artificial kidney. The artificial kidney offers important benefits for patients. For instance, they no longer have to go to hospital every other day for dialysis. They also get more control over their own treatment.
The wearable artificial kidney is an initiative of the Nierstichting. Development started in 2008 with a series of preliminary studies on a smaller and lighter version of the existing dialysis device. The device had to be suitable for both shorter and longer dialysis treatments, which should be able to take place both during the day and at night.
Nextkidney
The Nierstichting saw that innovation in dialysis care was lacking. The foundation therefore founded the company Nextkidney in 2014 in cooperation with two international partners: the Swiss company Debiotech and Singapore's Dialyss. The kidney patients' association is also involved in the project. Initially, the aim was to use a kind of backpack, which patients carry with them all the time. Feedback from patients led to an unexpected conclusion: patients turned out not to find such an innovation desirable. Especially since they do not want to carry around a device attached to their body all the time. Continuous access to the bloodstream was also a problem and not currently technically possible.
Therefore, the ultimate goal is a portable device that allows people to dialyze several times a week. This at the time and location that is convenient for them. Cooperation with the Singapore and Swiss partner led to the creation of Nextkidney. "The portable artificial kidney is now completely ready. The safety tests with the sorbent technology in Singapore have been carried out and the clinical tests in France, and then in the Netherlands, are now being prepared," explained Nierstichting director Tom Oostrom.
CE and FDA approval
With this, necessary steps have been taken to obtain CE approval in Europe and FDA approval in the United States (US). These approvals are required for marketing the artificial kidney. One advantage for the Dutch introduction is that health insurers CZ, Zilveren Kruis and Menzis have been closely involved in the development for years. With Nextkidney, the health insurers are preparing pilots in Dutch hospitals. The parties are also working on the organisation of care. Because to make home dialysis attractive to a large group of people, Oostrom says it is vital that dialysis care is organised differently.
With the help of the wearable artificial kidney, the Nierstichting wants to improve the quality of life of kidney patients and extend their life expectancy. The foundation also wants to reduce the cost of dialysis treatment. This is possible by using less dialysis fluid and reducing the amount of professional care support needed.
6×2 hours of dialysis
The first version of the artificial kidney should be able to dialyze patients at a frequency of six times two hours a week. This is a new form of dialysis treatment for the Netherlands, reports the Nierstichting. Medically, 6×2-hour dialysis is better than 3×4-hour dialysis because it leads to fewer fluctuations in blood values and fluids. The Kidney Foundation also points out that there is a lot of international interest in this form of dialysis treatment. The focus on 6×2-hour dialysis therefore helps bring the artificial kidney to market faster. In time, the Kidney Foundation wants to further develop the device for other forms of dialysis, including 3×4-hour and overnight dialysis.
The wearable artificial kidney now bears the name NeoKidney. Dutch/Swiss company Nextkidney is marketing the device. In doing so, it receives support from major Dutch health insurers, several national and international researchers and patient and professional associations. To conduct clinical trials with patients and explain it to the market, Nextkidney is looking for investors. A crowdfunding campaign has been launched for this purpose.
Further information is available here.
By: Wouter Hoeffnagel
Photo: Darko Stojanovic via Pixabay
