Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource
Baxter International Inc. (NYSE:BAX) has received FDA clearance for its Homechoice Claria automated peritoneal dialysis (APD) system, featuring the Sharesource connectivity platform. This innovative system is designed for both adult and pediatric patients, enhancing remote patient management and promoting home dialysis growth. With over 6 million home dialysis treatments facilitated by Sharesource in the U.S., the new system aims to improve patient education and care efficiency. Homechoice Claria is slated for U.S. availability in the coming weeks.
- FDA clearance for Homechoice Claria enhances Baxter's APD portfolio.
- Sharesource platform supports over 6 million U.S. home dialysis treatments.
- System designed for both adult and pediatric populations, expanding market reach.
- None.
DEERFIELD, Ill.--(BUSINESS WIRE)--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:
- 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.
Homechoice Claria with Sharesource will be available in the U.S. in the coming weeks. More information is available at Claria.Baxter.com.
About Baxter
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.
The Homechoice Claria APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the home healthcare environment, including comparable use in professional healthcare facilities.
This release includes forward-looking statements concerning Homechoice Claria and Sharesource, including anticipated availability and potential benefits associated with their use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
Baxter, Homechoice Claria, Amia, CKD&Me and Sharesource are registered trademarks of Baxter International Inc.
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
