FDA clears Baxter's connected, in-center dialysis machine

A patient receives hemodialysis
The machine can be used with the company’s Theranova membrane, which filters out a wider range of molecules and toxins from the bloodstream. (Getty/Mailson Pignata)

Baxter has received an FDA clearance for its latest, portable dialysis machine designed to connect directly with electronic medical records for patients’ prescriptions and treatment data.

The company’s AK 98 hemodialysis machine is not designed for home use or self-care, but to assist healthcare providers with the logistics of administering multiple treatment sessions per day with the same unit. 

The new regulatory green light follows the agency’s OK late last year for its in-home, peritoneal dialysis system, as well as a de novo clearance for a new type of blood filter that better simulates the work of the human kidney.

The AK 98 also provides a customizable, app-like user interface, streamlined set-up processes and the ability to self-clear warnings and alerts, such as when fluid pressure and flows are corrected following patient movement. 

The system, designed for patients weighing at least 55 pounds, has been previously available internationally and will be launched in the U.S. in the coming weeks, according to Baxter. 

RELATED: Baxter nets FDA de novo clearance for a new class of dialysis filter, closer to the human kidney

The machine can be used with the company’s Theranova membrane, which filters out a wider range of molecules and toxins from the bloodstream—including those associated with the chronic inflammatory and cardiovascular conditions seen in patients suffering from kidney failure.

Over the course of 2020, Baxter’s renal care sales grew about 3% compared to 2019, to about $3.7 billion, while its acute treatment division—including continuous renal replacement therapies given in intensive care units, which the company received an emergency COVID-19 authorization for last August—increased by 38% to $740 million. 

The company said it plans to make additional investments this year in its manufacturing capacity, in response to U.S. regulatory changes in chronic kidney disease payments launched in 2019, which may increase demand for peritoneal dialysis products among patients with end-stage renal disease.