Home Hemodialysis Machines: A Practical Demonstration. FDA approved for home hemodialysis

Transcription

1 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 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

2 Home hemodialysis renal replacement devices Baxter VIVIA Hemodialysis System Fresenius NxStage System One and One S Fresenius PAK Sorbent Hemodialysis System PHYSIDIA S³ Tablo Quanta SelfCare + Baxter VIVIA Hemodialysis System 2

3 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VIVIA Hemodialysis System Aksys founded January 12, 1991 Aksys approved for home hemodialysis March 2002 Aksys PHD withdrawn from market because of financial issues January 2007 Aksys technology purchased by DEKA Research March 2007 Baxter entered into relationship with DEKA Research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

4 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

5 Fresenius History of (Fresenius) FMC 2008 Series Fresenius introduced the Baby 2004 Baby withdrawn from market 2008 Baby FDA approved for home therapy

6 machine w/ WetAlert & bibag system TM Machine Features and Benefits Many Dialysis Options Customize prescription to individual needs Dialysate choices Treatment frequency flexibility Familiar Platform Based on same platform as other Fresenius Renal Technologies machines ~30 years proven and reliable Same clinical/technical training for staff Ergonomic short cabinet Safety Enhancements Programmable BP alarm limits DIASAFE Plus filter (standard) Optional WetAlert wireless wetness detector Convenience Features Touchscreen Integrated heparin pump Dim function Help screens bibag on-line dry bicarbonate concentrate Integrated blood pressure cuff 6

7 WetAlert Wireless Wetness Detector Optional WetAlert wireless wetness detector Integrated safety enhancement Blood (wetness) detected Audible and visual alarm Venous line clamps Blood pump stops bibag Bicarbonate Made Easy Hygienic delivery of bicarbonate Convenient handling with lightweight packaging Easy top connectology Less storage and preparation space Two flexible bag sizes Environmentally-friendly with less waste 7

8 Machine provides all types of hemodialysis, standard platform, reliable and easy to maintain, provides ultrapure water, uses standard supplies Automated prime and rinse back, integrated blood pressure monitor and a heparin pump Dialysate concentration can be adjusted as in-center machines Patient interface assists patients with setup and interacts with alarms; Remote real-time monitoring is provided by icare connectivity. WetAlert, a wireless wetness monitor at the needle site will stop the blood pump if the alarm is activated. bibag Bicarbonate Made Easy improves set up NxStage System One and One S 8

9 History of NxStage System One & One S NxStage founded December 1998 NxStage approved for hemodialysis July 2003 Nxstage approved for home hemodialysis June 2005 Pure Flow approved 2008 Nx2me Connected Health approved October 2013 NxStage System One S approved November 2013 NxStage approved for nocturnal home hemodialysis November 2014 The Cycler and Cartridge Simple interface using shapes, colors, and diagrams to aid in operation of system Color coded cartridge clamps to match fluid pathways TM0571, Rev. A 9

10 Flexible Treatment Options PureFlow SL Package Express Package TM0571, Rev. A PureFlow SL Dialysate Preparation TM0571, Rev. A Designed for simplicity, ease of use, and patient safety Compact, self-contained, disposable deionization (DI) water filtration system Reduces monthly supply needs when compared to using premixed bagged dialysate Simple faucet or under sink connection and standard electrical outlet are all that are required to operate 10

11 Real-time alarm troubleshooting gives patients support when they need it. APMXXX Rev. X 21 Nx2me provides convenient and timely access to monitor patient well-being. APMXXX Rev. X 22 11

12 NxStage is the first company to bring Home Nocturnal Hemodialysis to patients. The FIRST and ONLY system cleared by FDA for home nocturnal hemodialysis Designed to make home nocturnal therapy simple and practical with all of the existing benefits of the System One Simple user interface Simple home connections Water-sparing dialysate generation Drop-in cartridge, easy clean-up Portable APMXXX Rev. X 23 Machine is a cycler (peritoneal dialysis cycler platform), disposable drop-in cartridge with blood and dialysate lines and dialyzer attached No blood or dialysate interface; disinfection involves removing the cartridge and wiping down the machine. Ultrapure dialysate in sterile 5-L bags or produced by Pure Flow system Pure Flow; disposable deionization water filtration system, faucet or an under-sink connection, standard electric outlet; requiring no significant home remodeling Pure Flow makes a 60-L sack of lactate base dialysate in 7 hours, used for up to 96 hours from the time of preparation. Maintenance of the cycler and Pure Flow through FedEx 12

13 Maximum dialysate flow is 200 ml/min with System One and 300 ml/min with System One S Cycler is portable, weighing 72 pounds. Patient can travel only with sterile bags. There is no integrated heparin pump or automated blood pressure monitor. Nx2me Connected Health, creates a wireless connectivity to the clinic that uses an ipad app for patient entry and transfer of secure patient and treatment data. NxStage System One S can provide Short Daily and Nocturnal Dialysis. Limiting factor is 60 liter batch dialysate Fresenius PAK Sorbent Hemodialysis System 13

14 History of the PAK Sorbent Hemodialysis System REDY (Recirculating Dialysis System) 1975 Renal Solutions founded August 2000 Renal Solutions Allient approved for hemodialysis June 2005 Renal Solutions was purchased by Fresenius November 2007 Intellectual rights of Xcorporeal purchased by Fresenius 2009 Sorbent Dialysis (9L/Rx) Cartridge Effluent Reservoir Fresh Dialysate Electrolytes K, Mg, Ca QB Used Dialysate This device is currently being evaluated by the FDA and is not available for use in the USA ADC David Updyke presentation

15 How Sorbents work ADC David Updyke presentation 2010 Fresenius Medical Care NA PAK Sorbent Hemodialysis System Currently under review by FDA Not for Sale in the US Expected Features: Proven Technology Over 6 Million Sorbent Treatments Environmentally Sound Only 9 Liters of Water Required Reduced Power Usage compared to Traditional Single Pass Equipment Recyclable Sorbent Cartridge Flexible Treatments 3 times/week Every Other Day Short Daily Ease of Use User Friendly Touch Screen Disposable Blood and Dialysate Circuit No internal disinfection Required Portability Separates in Two Easily Transportable Pieces PAK Sorbent Hemodialysis System, ADC , Fresenius Medical Care, All Rights Reserved Page 30 15

16 Machine designed for HHD, portable, cartridge set up, automated prime and rinse back and wipe down disinfection, friendly patient interface improves training time, transmits treatment data back to the unit and WetAlert monitoring Sorbent technology (regeneration of dialysate) results in only 9 liters tap water needed per treatment, no home set up No heparin pump, no blood pressure cuff Will need to educate Nephrologist about sorbent dialysis technology PHYSIDIA S³ 16

17 HISTORY Courtesy Dr. Roula Galland VALEMONT Research and development Design validation E. Herriot Lyon Hospital Animal trials 2004 Human trials (CPP) 2005 PHYSIDIA CREATION November 2010, 100% owned subsidiary of OEM DEVELOPMENT Stock ownership: Regional Funds INDUSTRIAL DEVELOPMENT S³ device Dialysate bags Dialysate cassette Arterial and venous lines Courtesy Dr. Roula Galland 17

18 Courtesy Dr. Roula Galland Machine designed for HHD, cartridge set up, automated prime, patient interface improves training time, transmits treatment data after and real time. Portable weight 44 lbs. Four chamber pumping system design provides Hemodialfiltration All dialysate made in sterile bags delivered to patient No heparin pump, no blood pressure cuff Can only deliver short daily and extended more frequent dialysis 18

19 Tablo History of the Tablo Home Dialysis Plus founded in March 2003 Transition of company to a Silicon Valley-based company became.outset Medical and developed the Tablo 19

20 20

21 Machine provides single-pass dialysate, a touch-screen patient interface to shorten put on and take off, alarm interaction, and wireless automatic treatment data transfer Ultrapure water is produced in real time with Microfluidic Heat Exchange flash pasteurization of incoming tap water Wide-ranging rates of blood (50-400) and dialysate ( ) flow for treatment flexibility Integrated water source 21

22 Quanta SelfCare + -Not available for sale in the United States- 22

23 About Quanta Based in Warwickshire, England Innovative Dialysis Machine Development Services implementing home/self-care programs Cooperates with patients & carers & UK dialysis teams Clinical guidance from leading renal specialists in Europe and US identified areas for innovation SelfCare+ - Technology Platform Single pass System Up to 800 ml/min Reverse Osmosis or bags Bicarbonate HF dialysis Conventional dialysers Small & portable Versatile Treatment Regimen Dialysis Dose Treatment location -Not available for sale in the United States- 23

24 Disposable Cartridge Platform Technology Dosing of acid & bicarbonate Conductivity & temperature sensing & control Flow Balancing & UF Supports all therapy regimens Facilitates unlimited dialysate Minimises need for disinfection Enables small & simple machine 47 Machine designed for HHD and in-center self-care, with cartridge setup, automated prime and rinseback, and touchscreen patient interface, store and transmit treatment data real time or after treatment Machine has a disposable pumping system, thus allows it to provide a high-performance single-pass hemodialysis system Portable weighing 64 pounds Standard supplies for machine, patient can travel with sterile bags, separate water treatment source for home setup No integrated heparin pump or automated blood pressure monitor 24

25 The Wearable Artificial Kidney (WAK) Wearable Artificial Kidney (WAK) Developed by Dr. Victor Gura Small clinical trial completed NIH/FDA grant at several sites FDA approval in process Clinical trial in the future Courtesy Dr. Bessie Young 25

26 Home hemodialysis in 2013 Questions 26