The AK 98 is a portable and easy-to-use system developed for the delivery of hemodialysis treatments
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Baxter International has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation Artificial Kidney 98 (AK 98) hemodialysis machine.
The AK 98 is a portable and easy-to-use system developed for the delivery of hemodialysis (HD) treatments.
The encrypted and two-way connectivity capabilities of the AK 98 system allow to pull prescriptions directly from the electronic medical record (EMR) for simplified workflow and data handling.
Baxter’s next-generation system’s feature allows to self-clear already corrected pressure alarms and eliminate unnecessary stoppage of treatment due to brief pressure fluctuations usually related to patient movement.
The system also features an advanced and customisable user interface with app-like functionality, which will help simplify prescription management and treatment supervision.
The AK 98 dialysis machine is designed for intermittent hemodialysis, as well as isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician.
Developed to use for patients with a bodyweight of 25kg or more, the system has to be used by trained operators when prescribed by a physician in chronic care dialysis or hospital care environment.
According to the company, the AK 98 is used in over 90 countries across the globe and will be available in the US in the coming weeks.
Baxter US renal care business general manager Gavin Campbell said: “We designed this latest version of our AK 98 system to help dialysis providers minimize the operational challenges that can come with administering multiple hemodialysis sessions per machine per day.
“With our recent De Novo authorization of Theranova, our novel dialysis membrane, our latest innovations to support HD provide our customers with choices for therapy and treatment modality.”
In September last year, Baxter secured De Novo authorisation from the FDA for its Theranova dialysis membrane.