Baxter announces FDA 510(k) approval for clearance of Homechoice Claria peritoneal dialysis system with Sharesource.

Baxter International Inc. announced the FDA clearance of the Homechoice Claria automated peritoneal dialysis (APD) system with Sharesource connectivity platform. Homechoice Claria combines a simple user interface with the benefits of Sharesource, the only two-way remote patient management platform for patients on peritoneal dialysis in the U.S. Homechoice Claria is cleared for both adult and pediatric populations. The clearance follows the recent finalization of the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) payment model, which aims to significantly increase the number of new patients with kidney failure who receive home dialysis and/or organ transplants. Enabling Enhanced Care with Remote Patient Management : With one in four APD patients globally benefitting from Baxter’s two-way remote patient management technology, Sharesource offers patients and clinicians the ability to stay closely connected to proactively address key aspects of peritoneal dialysis (PD) therapy. Through the platform’s accurate, daily treatment data and analytics, clinicians can manage patients remotely and make timely therapy decisions while keeping patients safely at home. Clinicians using Homechoice Claria with Sharesource also have greater visibility to patient adherence patterns, which may allow for early intervention and an increased focus on proactive care. To date, more than 6 million home dialysis treatments completed in the U.S. have been enabled by Sharesource, with over 20 million PD treatments managed around the world. Homechoice Claria offers enhanced features that facilitate added convenience for patients and clinical teams, as well as best-in-class educational companions to further simplify the PD experience. For patients, intuitive control buttons and an easy-to-read screen complement straightforward instructions in 38 languages. To extend patients’ learning beyond the clinic, MyClaria – a web-based app included as part of the Homechoice Claria system – features step-by-step, voice activated and enabled instructions to guide patients through therapy. For clinicians, MySharesource – also a web-based app – is a resource featuring step-by-step guidance and quick demo videos on how to use the Sharesource platform.