The United States Food and Drug Administration has granted 510(k) clearance to Baxter International Inc.’s AMIA automated peritoneal dialysis (APD) system with the Sharesource web-based remote connectivity platform. The device is approved to provide peritoneal dialysis for the treatment of end-stage renal disease.
Baxter said it anticipates launching the system in the United States in 2015.
The AMIA APD system uses features such as voice guidance, a touchscreen control panel and the Sharesource two-way connectivity platform. Sharesource allows physicians to access their home patients’ historical treatment data and deliver individual prescriptions remotely. The system also features animated graphics and automated step-by-step instructions..
”PD is an important treatment option for many patients with kidney disease seeking home-based therapy,” said Jaime Uribarri, MD, Department of Nephrology, Mt. Sinai Hospital, NY. ”We welcome new technology that allows patients to start and administer their physician-prescribed PD therapy at home.”
The AMIA APD system was developed in collaboration with DEKA Research and Development Corporation