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14 April 2022

Tablo Haemodialysis System, US

The Tablo Haemodialysis System is a self-contained dialysis system approved to treat both acute and chronic dialysis.
Tablo® is a haemodialysis delivery system developed by Outset Medical for the treatment of patients with acute and chronic kidney disease. Credit: Business Wire.
The Tablo system is a self-contained, low-cost dialysis delivery console. Credit: Outset Medical.
Around 100,000 new patients in the US require dialysis treatment every year. Credit: Business Wire.

Tablo® is a mobile haemodialysis system developed by Outset Medical for the treatment of patients with acute and/or chronic renal failure.

The US Food and Drug Administration (FDA) granted 510(k) clearance to the haemodialysis system in November 2016. It was also approved for use in patients at their home in April 2020, becoming the first system of its kind to receive such approval.

The Covid-19 virus has been found to compromise kidney function in affected patients, overwhelming dialysis services in hospitals during the pandemic.

In May 2020, Outset Medical, in collaboration with the US Department of Health and Human Services, delivered 50 Tablo haemodialysis systems to hospitals in emergency locations in New York City and Long Island.

The Covid-19 pandemic has increased the urgency for providing dialysis patients with options for various care settings, including home.

In November 2021, the Centres for Medicare & Medicaid Services (CMS) approved Tablo for the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES).

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 will enable additional reimbursement for Tablo home dialysis treatments.

Also in November 2021, Outset Medical received 510(k) approval from the FDA for a new sterilisation technique of the cartridge used in Tablo. This approval facilitated 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.

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.

The fluidic systems function as a water purification system, while the dialysis delivery system performs the dialysis activities.

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.

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 is also the first system of its kind to receive approval from the FDA in April 2020 for use in patients in their homes.

Features of the Tablo haemodialysis system

The Tablo haemodialysis system features expanded wireless data transmission capabilities, with two-way cloud communication. This allows users to access treatment data anywhere.

The touchscreen interface provides three-dimensional animations and conversational instructions to navigate the user through the system settings and treatment in a simple way. The 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, treatment duration flexibility ranging between 30 minutes and 24 hours with a change in supplies, and an integrated blood pressure cuff. The system also reduces the training time for operators to a few hours.

Water specifications of the system

Environmental Protection Agency (EPA) quality drinking water, with an incoming temperature of between 5oC and 32oC and an incoming pressure of 30-80 PSIG, is fed into the Tablo system.

The filtration system includes integrated sediment, carbon, reverse osmosis (RO) and an ultrafilter, while the output of purified water meets Association for the Advancement of Medical Instrumentation (AAMI) standards.

Clinical study of the Tablo haemodialysis system

A total of 30 patients were studied in an eight-week, prospective, multi-centre, home haemodialysis trial to evaluate Tablo’s safety and effectiveness at home.

Patients received four treatment periods, in which dialysis was performed four times a week for 21 consecutive weeks. This included 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.

The study demonstrated that the system is easy to learn and functions in an in-home setting. It allowed at-home dialysis of the patient while remaining functional during treatment. More than 500,000 people in the US currently need dialysis treatment three times or more in a week, which takes around four hours for each treatment. Every year, around 100,000 new patients start dialysis treatment.

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