• Document: Home Hemodialysis Machines: A Practical Demonstration 2015 Chicago ISHD Hemodialysis University October 2, 2015 Chicago, Illinois Retired Clinical Nephrologist Lynchburg Nephrology Physici...
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Home Hemodialysis Machines: A Practical Demonstration 2015 Chicago ISHD Hemodialysis University October 2, 2015 Chicago, Illinois Retired Clinical Nephrologist Lynchburg Nephrology Physicians and Department of Nephrology at the University of Virginia Medical Director of Home Therapies in Lynchburg 1982-2013 FDA approved for home hemodialysis Only machines FDA approved for HHD • NxStage System One and System One S • Fresenius 2008 K@Home No machine FDA approved for Pediatric use Only machine FDA approved for Nocturnal Hemodialysis: NxStage System One and System One System All other machines used for HHD patients must be ordered by the physician off label 1 Home hemodialysis renal replacement devices Baxter VIVIA Hemodialysis System Fresenius 2008@Home NxStage System One and One S Fresenius PAK Sorbent Hemodialysis System PHYSIDIA S³ Tablo Quanta SelfCare + Baxter VIVIA Hemodialysis System 2 History of Baxter VIVIA Hemodialysis System • Aksys founded January 12, 1991 • Aksys approved for home hemodialysis March 2002 • Aksys PHD withdrawn from market because of financial issues January 2007 • Aksys technology purchased by DEKA Research March 2007 • Baxter entered into relationship with DEKA Research introducing VIVIA Hemodialysis System in 2013 in Europe as a new machine VIVIA: Baxter’s Investigational Home HD System Design Objectives: Enable patients to perform hemodialysis in the home Safety and ease of use VIVIA Treatment Device: Dedicated to a single patient Automates most activities, including: - Testing, priming and rinseback - Heparin administration - Fluid infusion - Non-chemical hot water disinfection Blood set and dialyzer qualified for up to 30 treatments. Access disconnect sensor NOT APPROVED BY THE FDA 3 VIVIA: Baxter’s Investigational Home HD System • VIVIA Water Device: Fully integrated with the Vivia Treatment Device Designed to minimize water usage, yet allow high volume dialysis. • Sharesource • Connectivity platform which provides safe and secure access by clinic to monitor patient’s treatment. NOT APPROVED BY THE FDA Baxter VIVIA hemodialysis system is designed to deliver high-dose hemodialysis at home. Machine provides reuse of the dialyzer and blood lines by means of heat disinfection and automatic prime and rinseback Integrated access disconnect system Animated, patient-friendly, graphic user interface and wireless connectivity to the clinic Integrated heparin pump; an integrated water treatment source and online dialysate generation. Device provides all types of hemodialysis It is not portable and does not have an integrated blood pressure monitor system. The device approved in European Community 2013 4 Fresenius 2008@Home History of 2008K@Home (Fresenius) FMC 2008 Series Fresenius introduced the Baby K@Home 2004 Baby K@Home withdrawn from market 2008 Baby K@Home FDA approved for home therapy 2010 5 2008K@home machine w/ WetAlert & bibag system 2008K@homeTM Machine Features and Benefits Many Dialysis Options Safety Enhancements • Customize prescription to • Programmable BP alarm limits individual needs • DIASAFE Plus filter (standard) • Dialysate choices • Optional WetAlert wireless • Treatment frequency flexibility wetness detector Familiar Platform Convenience Features • Based on same platform as other • Touchscreen Fresenius Renal Technologies machines • Integrated heparin pump − ~30 years proven and reliable • Dim function • Same clinical/technical training

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