Baxter (NYSE:BAX) said yesterday that it launched an FDA-cleared clinical trial of its on-demand peritoneal dialysis solution generation system intended to allow patients to make peritoneal dialysis solutions in small batches at home.
The system is designed to use a small water filtration device, concentrates and Deerfield, Ill.-based Baxter’s Amia automated peritoneal dialysis system to turn a patient’s tap water into dialysis solution as needed for therapy sessions.
Baxter said that it has enrolled the first patient in the trial, which looks to assess the efficacy and safety of the new system for participants over 12 weeks. The company said it hopes to use data from the trial to support a New Drug Application for the concentrates and 510(k) clearance for the device.
“We are on a journey to transform how kidney disease is identified, managed and treated, with a focus on improving outcomes for patients. Our on-demand technology is the cornerstone of our innovation pipeline, as we believe the technology will open up new possibilities for therapy delivery while improving the experience for patients today,” renal care biz GM Laura Angelini said in a press release.
In November, Baxter said that it expanded its share purchase program to $3.4 billion.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.