Baxter International has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Homechoice Claria automated peritoneal dialysis (APD) system with Sharesource connectivity platform.
The Homechoice Claria system combines a simple user interface with the benefits of Sharesource, which is claimed to be the only two-way remote patient management platform for patients on peritoneal dialysis in the US.
The system is approved for both adult and paediatric populations.
According to the company, Sharesource enables patients and clinicians to stay closely connected to proactively solve major aspects of peritoneal dialysis (PD) therapy.
The platform, through its daily treatment data and analytics, enables clinicians to manage patients remotely and take timely therapy decisions.
Homechoice Claria offers improved features to further simplify the PD experience
Homechoice Claria includes improved features that are designed to provide convenience for patients and clinical teams, in addition to educational companions to simplify the PD experience.
For patients, MyClaria, a web-based app, has been included in the Homechoice Claria system to provide step-by-step, voice activated and enabled instructions to guide them through therapy.
MySharesource is a web-based app for clinicians that offer step-by-step guidance and rapid demo videos on how to use the Sharesource platform.
Baxter US renal care business general manager Gavin Campbell said: “Our goal remains to expand accessibility to home-based therapy for U.S. patients with kidney failure.
“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 US.”
In September this year, Baxter International received De Novo authorisation from the FDA for its Theranova dialysis membrane.