Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource
DEERFIELD, Ill. - November 23, 2020
Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (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.1?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.
?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. ?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.?
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.2?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.
?When starting their patients on PD, clinicians are looking for ways to help manage their changing needs over time,? said Amy O?Brien, PD clinical specialist at Baxter. ?The combination of features, insights and resources available through?Homechoice Claria?with?Sharesource?creates an accurate, efficient tool for therapy management, resulting in peace of mind for patients and the healthcare providers who support them.?
Adding?Homechoice Claria?to its APD cycler portfolio enhances Baxter?s efforts to bring the benefits of?Sharesource?remote patient management to as many clinics and patients as possible in the U.S. Baxter will continue offering its?Sharesource-enabled APD cycler,?Amia,?which offers additional features to support patients, including a touchscreen user interface and built-in voice guidance. The introduction of?Homechoice Claria?follows several Baxter initiatives across the continuum of care to improve options for patients with kidney failure, including:
?1?Homechoice Claria product indications (please refer to the Instructions for Use for more information) 2?Firanek C. et al, Discrepancy between prescribed and actual APD prescription delivery: Identification using cycler remote management technology. EDTA 5-18-2017. Poster #MP557
- Launching?CKD&Me, an app providing customized disease and therapy education for the individual learning needs of patients with chronic kidney disease.
- Developing the?PD Excellence Academy, a first-of-its-kind curriculum providing education to PD nurses in one easily-accessible online resource.
?1?Homechoice Claria product indications (please refer to the Instructions for Use for more information) 2?Firanek C. et al, Discrepancy between prescribed and actual APD prescription delivery: Identification using cycler remote management technology. EDTA 5-18-2017. Poster #MP557