The system is desigend to produce sterile PD solutions using a small water filtration device designed to be placed in a patient’s home and integrated into its AMIA automated peritoneal dialsysis system, the Deerfield, Ill.-based company said.
“The FDA’s guidance is a pivotal milestone in advancing our new system forward for use by renal patients in an expedient manner. 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,” chronic renal biz GM Laura Angelini said in a press release.
Baxter said that it is hopeful to enroll the 1st patient in a clinical trial of the device beginning next year, with regulatory submission expected in 2019.
Last November, Baxter released data on its Sharesource remote patient monitoring and home-use Amia automated peritonial dialysis systems, touting its ability to improve early detection of adverse issue issues and faster treatment.
Data from a case study of Baxter’s Sharesource indicated that the system was able to identify a displaced catheter through an early alert and diagnosis, which was surgically repositioned, the company said.