Memorandum

Medtronic completes MiniMed 670G US pivotal study, on track for FDA submission before the end of June – March 9, 2016

Medtronic confirmed with us today that the US pivotal study for the MiniMed 670G/Enlite 3 hybrid closed loop is now complete – slightly ahead of the expectation shared in Medtronic’s 4Q15 call last week (“in the next few weeks”) and just a tiny bit bit later than when Dr. Fran Kaufman said “25 days” at ATTD (early February). The ClinicalTrials.gov page has not been updated yet. Medtronic remains on track to submit a PMA to the FDA before the end of June 2016, meaning a launch by April 2017 is still possible (though an ~10-12-month FDA review is potentially ambitious for a new pump platform, a new sensor, and the first true automated insulin delivery device in the US – we’ll see what happens and how fast FDA can move). As a reminder, the 670G launch timeline was set at JPM 2015 and confirmed at JPM 2016 in January. Medtronic’s call last week noted that “>75% of patients” enrolled in the 670G US pivotal study have opted-into the FDA’s continued access program (the company said 80% today), suggesting strong patient enthusiasm for the device, particularly in the clinical trial participants that are likely early adopters and have a high bar. The pivotal study is single-arm and has only 124 completers, so it won’t be ideal for comparing the system’s efficacy to other interventions (the planned ~1,000 patient 670G outcomes study will do that). Still, we wonder what the data will show and when it will be presented (presumably not by ADA 2016). We’re elated to see this trial completing ~ two to three months earlier than originally forecasted and hope the FDA process goes smoothly. For more on the 670G, see our Medtronic 4Q15 report and our latest Automated Insulin Delivery competitive landscape.

-- by Adam Brown and Kelly Close