The Food and Drug Administration (FDA) has cleared Outset Medical’s Tablo Haemodialysis System for patient use in the home.
PRNewsfoto/Outset Medical
The new home clearance expands Tablo's existing labelled indication for use in acute and chronic care facilities.
In mid-2019, President Trump and United States Department of Health and Human Services Secretary Alex Azar announced an Executive Order to help Americans with kidney failure. A major component of the policy was ensuring 80% of all new dialysis patients start therapy at home or get transplanted by 2025. The emergence of COVID-19 further heightens the urgency for giving current in-centre dialysis patients the option to treat at home.
Leslie Trigg, Outset Medical’s chief executive officer, said: "Tablo was designed to simplify dialysis, making it easier and more accessible for patients to take advantage of the safety, convenience and flexibility of dialyzing at home. We are proud to offer them this new, life-enhancing option, particularly in light of the COVID-19 related challenges dialysis patients and providers are experiencing."
A prospective, multicentre, home haemodialysis trial with 30 patients was completed in 2019 and confirmed the Tablo system is safe and effective for home use. The results were published in November 2019 in Haemodialysis International.
Troy Plumb, the principal study investigator, said: "My patients, colleagues and I are excited for Tablo to be available for home use. The trial made it clear the system is easy to learn and performs well in the home environment. I believe that Tablo will open up opportunities for patients to pursue home haemodialysis and take more control over their lives and care."
Outset will begin a controlled rollout for home use at select sites over the coming months to ensure training and support for Tablo home patients. This program will be balanced with the need to supply health systems, hospitals, and clinics with devices to support a surge of demand for dialysis treatments driven by COVID-19.
Tablo was designed in Silicon Valley to reduce the cost and complexity of dialysis care. Requiring only an electrical outlet and tap water to operate, the mobile Tablo system frees patients and providers from expensive clinic infrastructure. The machine's functionality enables it to serve as a dialysis clinic on wheels. The system has wireless data, sensor-based automation and an animated touchscreen.
