FDA approves Outset Medical’s Tablo dialysis machine for home use
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The FDA has approved Outset Medical’s Tablo Hemodialysis System for use in a home setting after positive results from 30 patients who completed a year-long trial.
“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,” Leslie Trigg, Outset Medical’s CEO, said in a press release. “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.”
Troy Plumb, MD, the principal study investigator and division chief of nephrology and associate professor of medicine at the University of Nebraska Medical Center College of Medicine in Omaha, said in the release, “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 hemodialysis and take more control over their lives and care.”
Outset had received FDA approval for use of the Tablo in hospital settings and in outpatient dialysis facilities, a market it already shares with NxStage Medical’s SystemOne. It is the first time that two dialysis machines specifically built for home use are available in the United States. CVS Health is conducting patient trials with a third home hemodialysis machine, called the Hemocare Hemodialysis System, designed by Segway inventor Dean Kamen.
According to the release, Outset was awarded a HHS contract last year for the use of Tablo in communities hit by natural disasters.
Michael Aragon, MD, chief medical officer for Outset, told Healio Nephrology that patients initially underwent treatments with the Tablo for 8 weeks in outpatient clinics. There was then a 4-week transition period (accompanied by training on using the machine at home, if needed), followed by 8 weeks of treatment in the home setting.
“Treatments occurred four times per week for 3.4 hours,” Aragon said.
Patients met the primary efficacy endpoint of the study (weekly standard of Kt/V of 2.1), with average weekly standard Kt/V being 2.8 in both the in-center and at-home periods. In addition, 94% (both in-center and at-home use) of patients met the secondary efficacy endpoint of delivery of ultrafiltration within 10% of prescribed ultrafiltration, Aragon said.
Outset designed the Tablo to use tap water to operate, and it includes wireless data, sensor-based automation and a touchscreen for patient use, the company said. – by Mark E. Neumann
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Disclosures: Aragon, Trigg and Plumb report no relevant financial disclosures.