First New Device Trial Completed for Home Hemodialysis In 15 Years
SAN JOSE, Calif., Nov. 7, 2019 /PRNewswire/ -- Outset Medical, a commercial-stage company delivering first-of-its-kind technology into the growing, global, dialysis market today announced publication of a multicenter, prospective, open-label study in Hemodialysis International. Titled "Safety and Efficacy of the Tablo Hemodialysis System for In-center and In-home hemodialysis," the 30-patient study met both the safety and efficacy endpoints. Tablo is currently FDA-cleared for use in hospitals and clinics and is under evaluation by FDA for use in the home.
Over 21 consecutive weeks, patients went through four treatment periods in which hemodialysis was prescribed four times weekly: one-week Run-In; eight-week In-Center; four-week Transition; eight-week In-Home. The data showed a mean weekly standard Kt/V ≥ 2.8 for participants during the In-Center and In-Home treatment periods (compared to the trial endpoint of a standard Kt/V ≥ 2.1) and delivered ultrafiltration (UF) within 10% of prescribed UF. There were no device-related pre-specified adverse events throughout the trial. All patients who started the home arm with Tablo completed it, resulting in a 0% home arm drop-out rate.
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Results from Prospective, Multicenter Trial Evaluating the Use of the Tablo® Hemodialysis System for Home Dialysis Released at the American Society of Nephrology Scientific Meeting
Via: PR Newswire