Medtronic Approved to Start Pivotal Trial to Evaluate New Extended Wear Infusion Set
DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it received investigational approval from the U.S. Food and Drug Administration (FDA) to proceed with a pivotal trial for a new extended wear infusion set. The goal of the study will be to collect clinical data to support the use of the extended wear infusion set for up to seven days – more than twice the length of time that any infusion set can currently be used. The multi-center, non-randomized, prospective single arm study will enroll up to 150 subjects, aged 18 to 80, with type 1 diabetes on insulin pump therapy.
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