Tablo® is a first-of-its-kind, fully integrated mobile haemodialysis system developed by Outset Medical, a medical technology company based in the US, for the treatment of patients with acute and/or chronic renal failure.
Unlike traditional dialysis machines that are large and stationary, Tablo is a compact, portable system that can be used in various healthcare settings, including hospitals, clinics, and patients’ homes.
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Outset Medical delivered 50 Tablo haemodialysis systems to emergency locations in New York City and Long Island in collaboration with the US Department of Health and Human Services in May 2020.
In April 2024, Outset Medical signed a multiyear agreement with US Renal Care to provide the Tablo system for home dialysis to patients and caregivers.
This agreement enables US Renal Care to offer the Tablo system as a home dialysis option across the 33 states where it operates.
Regulatory approvals for Tablo haemodialysis system
The US Food and Drug Administration (FDA) granted 510(k) clearance to the haemodialysis system in November 2016.
The system was approved for use in patients at their homes in April 2020, becoming the first of its kind to receive such approval.
The Centres for Medicare & Medicaid Services approved Tablo for the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) in November 2021.
The TPNIES aims to increase access to new and innovative medical technologies for end-stage renal disease (ESRD) patients by addressing barriers in the ESRD-bundled payment system.
The approval enables additional reimbursement for Tablo home dialysis treatments.
Outset Medical received 510(k) approval from the FDA for a new sterilisation technique of the cartridge used in Tablo in November 2021.
The approval facilitated the full production of the device in North America.
The localisation of cartridge production eliminates the costs associated with air freight delivery of the cartridges, streamlining distribution and logistics.
The FDA granted 510(k) approval for TabloCart™ with prefiltration, an optional accessory for the haemodialysis system, in May 2024.
Tablo haemodialysis system details
The Tablo device is a self-contained, low-cost haemodialysis delivery console comprising fluidic systems and a dialysis delivery system with high-flux dialysers.
It measures 35.2in high, 17.7in wide and 26.9in deep, and has a dry weight of 88kg.
The fluidic systems function as a water purification system while the dialysis delivery system performs the dialysis.
The system’s blood flow rate is up to 400ml a minute, with an extracorporeal circuit volume of 140ml, a maximum ultra-filtration rate of 2,000ml an hour, and a dialysate flow rate of 100ml, 200ml or 300ml a minute.
The system is suitable for providing extended therapy for 24 hours, slow low-efficiency dialysis, standard haemodialysis (HD), isolated ultrafiltration (UF Only), and sequential therapy, that is HD-UF and UF-HD.
Tablo’s sensors automate a larger part of the setting, procedure, management, and maintenance of the system.
The Tablo cartridge does not require manual set-up, thus reducing the setting and take-down time. The dialysate on-demand allows water to be purified and dialysates to be produced in real-time.
Tablo haemodialysis system features
The haemodialysis system features expanded wireless data transmission capabilities, with two-way cloud communication, which allows users to access treatment data anywhere.
The system enables home-based dialysis and minimises the need for specialised infrastructure.
It offers flexible treatment duration ranging from five minutes up to 24 hours with no changeover in supply.
Its touchscreen interface provides three-dimensional animations and conversational instructions to simply navigate the user through the system settings and treatment.
Regular automated updates improve the system’s ability with time. The wheels provide mobility to the system, enabling it to work in diverse care settings.
Other features include automated self-cleaning, saline bolus and tracking abilities, single-touch rinse-back, and an integrated blood pressure cuff.
The system also reduces the operator training time to a few hours.
TabloCart for Tablo haemodialysis system
TabloCart is a specialised cart designed to support the Tablo haemodialysis system, providing ease of transport, storage, and enhanced functionality in various healthcare settings.
The cart features 360-degree rotating wheels, facilitating movement across different surfaces.
Its directional locking rear wheels offers enhanced manoeuvrability for seamless movement in various clinical environments.
With TabloCart, the Tablo system eliminates the need for heavy lifting or repeated setup.
It comes in two versions, one with water prefiltration capabilities and another with additional storage drawer options.
TabloCart offers three customisable prefiltration options.
The prefiltration option is designed to make the process of prefiltration easier, increase filter volume and withstand even the toughest water conditions.
The option includes the addition of a water pressure booster pump to enhance incoming water pressure, and a visual display for filter life and cart servicing.
The cart with storage drawer option is equipped with compartments and shelves, designed to securely hold supplies such as test strips, saline and straws.
It has designated compartments to ensure that all essential elements of the system such as tubing, filters and disposables are stored in a structured manner and readily accessible when needed.
Proper organisation reduces the risk of misplacement or damage to vital equipment, promoting streamlined workflows and minimising downtime during dialysis treatment.
The TabloCart is equipped with power outlets and cable management systems, allowing for easy connection and charging of the system’s components.
It includes built-in safety features such as secure attachment points for tubing and cables, ensuring that all connections remain intact during transportation.
These safety measures promote the reliable and secure delivery of dialysis treatment, minimising the risk of accidents or equipment malfunction.
Water specifications of the Tablo system
Quality drinking water meeting the Environmental Protection Agency standards, with an incoming temperature of between 5℃ and 32℃ and an incoming pressure of 30-80 PSIG, is fed into the Tablo system.
The filtration system includes integrated sediment, carbon, reverse osmosis and an ultrafilter while the output of purified water meets Association for the Advancement of Medical Instrumentation standards.
Maintenance details of the Tablo solution
The Tablo haemodialysis system is disinfected daily using automated heat disinfection. Full and quick chemical disinfection cycles are also run to maintain the system.
Clinical study on the Tablo haemodialysis system
A total of 30 patients were studied in an eight-week, prospective, multicentre, home haemodialysis trial to evaluate Tablo’s safety and effectiveness at home.
The patients received four treatment periods, in which dialysis was performed four times a week for 21 consecutive weeks, which included a one-week run-in, eight weeks in-centre, four-week transition and eight weeks in-home.
The trial showed no device-related adverse events in patients.
It demonstrated that the system is easy to learn and functions in an in-home setting. It allowed at-home dialysis of the patients while remaining functional during treatment.
More than 500,000 people in the US currently need dialysis treatment thrice or more a week, which takes approximately four hours for each treatment.
Every year, 100,000 new patients start dialysis
