FDA OKs Baxter's Automated Home Peritoneal Dialysis System

Megan Brooks

October 16, 2015

The US Food and Drug Administration (FDA) has cleared Baxter International's AMIA automated home peritoneal dialysis (APD) system with remote connectivity over the Internet, using the company's Sharesource patient portal, according to a company news release.

The AMIA APD system is the only device available in the United States that incorporates "patient-centric features" such as voice guidance, a touchscreen control panel, and the Sharesource two-way connectivity platform, the company said in the release. Sharesource allows physicians to access their home patients' historical treatment data and deliver individual prescriptions remotely.

The system includes animated graphics and automated step-by-step instructions designed to increase the efficiency of home therapy training and administration for patients with end-stage renal disease, the company said.

"PD is an important treatment option for many patients with kidney disease seeking home-based therapy," Jaime Uribarri, MD, from the Department of Nephrology, Mt. Sinai Hospital in New York City, said in the release. "We welcome new technology that allows patients to start and administer their physician-prescribed PD therapy at home."

There are currently more than 600,000 people in the United States living with end-stage renal disease, Baxter notes.

The AMIA APD system was developed in collaboration with DEKA Research and Development Corporation to support home PD therapy patients with "more intuitive" device operation, while providing remote connectivity with physicians, the company notes.

Baxter anticipates launching the AMIA APD system with the Sharesource patient portal in the United States this year.


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