FDA clears Baxter's virtually connected, in-home peritoneal dialysis system

Baxter has received clearance from the FDA for the latest version of its automated peritoneal dialysis system designed for home use, combining it with a digital platform that aims to help patients with kidney disease manage their care remotely.

The Homechoice Claria system was cleared for both adults and children. Its interface is available in 38 languages and features step-by-step, voice-activated instructions through an accompanying app to help guide the user through therapy.

Meanwhile, Baxter’s two-way Sharesource platform—already used with more than 6 million home dialysis treatments in the U.S. and over 20 million peritoneal treatments globally—provides data to clinicians and notifies them if issues occur during treatment, including if the patient goes off their therapy schedule.

Sharesource also connects to Baxter’s touchscreen-enabled models, marketed as the Amia automated peritoneal dialysis device in the U.S. and Canada, and as the Kaguya system in Japan.

“Our goal remains to expand accessibility to home-based therapy for U.S. patients with kidney failure,” said Gavin Campbell, general manager of Baxter’s U.S. renal care business, which aims to make the system available in the coming weeks.

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“Homechoice Claria with Sharesource will support accelerated home dialysis growth by bringing the benefits of a two-way connected automated peritoneal dialysis system combined with a simple, intuitive device to more patients in the U.S.,” Campbell added.

The system follows several digital initiatives from Baxter aimed at improving renal care, including last year’s debut of its free smartphone app that provides customized information on chronic kidney disease, CKD&Me. The company also launched a virtual peritoneal dialysis academy this past August for U.S. nurses.

Meanwhile, in hemodialysis, Baxter received a de novo clearance from the FDA for a new class of blood filter, the Theranova cartridge, which sifts out a wider range of molecules to more closely resemble the work performed by the human kidneys.