Medtronic submits MiniMed 670G/Enlite 3 hybrid closed loop to FDA – June 27, 2016

Medtronic shared with us today that it has submitted the MiniMed 670G/Enlite hybrid closed loop system to the FDA, exactly on par with expectations shared in its 1Q16 and 4Q15 calls. The informative Analyst Meeting just prior to ADA called for a US launch by April 2017, implying an FDA review of ~9-10 months at the most. Following the positive June 2 FDA artificial pancreas webinar, that ambitious timing seems more realistic; of course, a lot has to go right since this is the first hybrid closed loop, a new sensor, and a new pump platform. We saw the single-arm, three-month 670G pivotal trial results at ADA 2016 two weeks ago: a strong 0.5% reduction in A1c from a low study baseline of 7.4%; time <70 mg/dl declined 44% (from 6% to 3%); and time <50 mg/dl declined 40% (1% to 0.6%). The glucose profiles really put into perspective how much this product shrinks variability, particularly overnight and in adolescents. It was an uncontrolled study, so we’ll have to wait for the planned 1,000-patient, three-arm, six-month outcomes study to see how this compares to pump alone and open-loop sensor-augmented pump (per ATTD). Many at ADA were psyched about the results, though there are still some big questions: Will Medtronic be able to manage patient expectations? Will this appeal to MDI users? Will there be a 670G upgrade program for current Medtronic pumpers? How big is the education and training gap? Will Medtronic use the same reimbursement model and pricing as sensor-augmented pump therapy? See our updated automated insulin delivery competitive landscape for a high-level view of the field, which shows at least seven systems with potential to be commercialized over the next few years. Meanwhile, we’ll have our ADA 2016 themes out later this week, with a lot more perspective on where the AID field stands and where it’s going.

-- by Adam Brown and Kelly Close