Home » Fractyl Laboratories Enrolls First Participant in Pivotal Trial of Type 2 Diabetes Procedure
Fractyl Laboratories Enrolls First Participant in Pivotal Trial of Type 2 Diabetes Procedure
Devices Research and Development
Massachusetts-based Fractyl Laboratories has announced that it enrolled the first participant in its pivotal trial of Revita Duodenal Mucosal Resurfacing (DMR), an outpatient endoscopic procedure for type 2 diabetes patients.
The trial, which is expected to enroll more than 300 patients at up to 35 sites in the U.S. and Europe, will support FDA clearance for the procedure, which is designed to remove the need for daily insulin. The DMR procedure received CE mark certification in April 2016.
DMR resurfaces the lining of a patient’s upper intestine. The trial is evaluating the procedure’s ability to grant durable insulin-free glycemic control in patients who aren’t getting adequate control on insulin therapy.