Baxter International Inc. is developing a peritoneal dialysis solution generation system that would produce sterile PD solutions in patients’ homes. The company said it has received guidance from the the U.S. Food and Drug Administration clarifying the regulatory pathway for the system, which would use a small water filtration device and would be integrated with the Amia PD system.
Baxter said the system will follow a regulatory pathway as a combination product, which is the process the agency uses for products that include a device and pharmaceutical component.
The system will be designed to reduce storage and weight handling requirements that come with traditional PD therapy.
“The FDA’s guidance is a pivotal milestone in advancing our new system forward for use by renal patients in an expedient manner,” said Laura Angelini, general manager of Baxter’s Chronic Renal business. “These technology advancements have the potential to greatly enhance home dialysis therapy for patients by providing solution generation on-demand and eliminating some of the barriers that today may keep patients from the lifestyle benefits that home dialysis offers.”
Baxter said it plans to have the first patient on therapy with the new system as part of a clinical trial in 2018. Regulatory submission is expected in 2019.
Baxter said the new system would provide physicians the flexibility to prescribe different dextrose concentrations for each dwell cycle, depending on each patient’s needs.
The company’s Amia PD system is currently in approximately 1,700 U.S. patients’ homes, according to Baxter.