Acute and/or chronic renal failure patients can be treated with the help of the Tablo® mobile haemodialysis system, which was created by US-based Outset Medical.
Tablo is a small, mobile device that may be utilized in a variety of healthcare facilities, including hospitals, clinics, and patients' homes, in contrast to conventional dialysis machines, which are big and stationary.
In November 2016, the 510(k) approval from the US Food and Drug Administration (FDA) was given to the hemodialyzer.
In April 2020, the treatment received permission for usage in patients at home, making it the first of its kind to do so.
In May 2020, Outset Medical shipped 50 Tablo haemodialysis units to emergency facilities in New York City and Long Island in coordination with the US Department of Health and Human Services.
Tablo received the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) from the Centers for Medicare & Medicaid Services (CMS) in November 2021.
By removing obstacles in the ESRD-bundled payment system, TPNIES intends to improve end-stage renal disease (ESRD) patients' access to cutting-edge medical treatments. Additional funding for Tablo home dialysis treatments is now possible thanks to the approval.
In November 2021, the FDA granted 510(k) approval to Outset Medical for a novel method of Tablo cartridge sterilisation. The certification permitted the device's full manufacture in North America.
Clinical investigation of the Tablo hemodialyzer
An eight-week prospective, multi-center, home haemodialysis trial involving 30 patients was conducted to assess the safety and efficacy of Tablo when used at home.
The patients had four treatment cycles, consisting of a one-week run-in, eight weeks in the center, a four-week transition, and eight weeks at home, during which dialysis was carried out four times per week for 21 continuous weeks. In the trial, there were no patient reports of device-related adverse events.
It shown that the technique works in a home environment and is simple to learn. It allowed patients to receive hemodialysis at home while still being able to function.
In the US, more than 500,000 people require dialysis three times a week or more. Each treatment lasts about four hours. 100,000 new people begin dialysis each year
Details of the Tablo hemodialysis system
The Tablo device is a standalone, reasonably priced haemodialysis delivery console made up of fluidic systems and a high-flux dialyser delivery system. Its dry weight is 88kg, and its dimensions are 35.2in high, 17.7in broad, and 26.9in deep.
While the dialysis delivery system carries out the dialysis, the fluidic systems serve as a method for purifying water.
The system has a maximum ultra-filtration rate of 2,000 ml per hour, a maximum blood flow rate of 400 ml per minute, a 140 ml extracorporeal circuit capacity, and a 100, 200, or 300 ml per minute dialysate flow rate. The device can be used to deliver extended therapy for 24 hours (XT), slow low-efficiency dialysis (SLED), standard haemodialysis (HD), isolated ultrafiltration (UF Only), and sequential therapy, which includes HD-UF and UF-HD.
A bigger portion of the system's setup, operation, management, and maintenance are automated by Tablo's sensors. The Tablo cartridge eliminates the need for manual setup, shortening the setup and takedown times. Water can be made clean and dialysates can be made in real-time thanks to the dialysate on-demand technology.
Features of the Tablo hemodialyzer
Users can access treatment data anywhere using the Tablo haemodialysis system's expanded wireless data transmission capabilities and two-way cloud connectivity.
The technology minimizes the demand for specialized infrastructure and allows for home-based dialysis.
Through its touchscreen interface, the user may easily navigate through the system settings and treatment with the help of three-dimensional animations and conversational instructions.
Over time, the system's functionality is enhanced by routine automated upgrades. The system is mobile thanks to the wheels, which enables it to function in various healthcare environments.
Additional features include an integrated blood pressure cuff, automated self-cleaning, saline bolus and tracking capabilities, single-touch rinse-back, and treatment duration flexibility ranging from 30 minutes to 24 hours with a change in supplies. Additionally, the method cuts down operator training to a few hours.
0 Comments
Post a Comment
Share your views