Memorandum

Medtronic Submits Non-Adjunctive Labeling to FDA for Guardian Sensor 3 CGM – July 23, 2019

Critical step for obtaining Medicare reimbursement of MiniMed 670G, competing with Tandem Control-IQ/Dexcom G6

Medtronic announced today that it has filed a PMA with the FDA to obtain non-adjunctive labeling of the Guardian Sensor 3 CGM as part of MiniMed 670G hybrid closed loop. This is on track with the 1Q19 plan for an “early” FY20 (April 2019-April 2020) filing. Medtronic confirmed that the filing actually went to FDA last month, in line with the ADA 2019 goal to file in June.

The critical labeling update will finally allow the 670G to apply for Medicare reimbursement as a therapeutic CGM – a long-time coming follow landmark FDA approval of the hybrid closed loop nearly three years ago.

We assume the FDA labeling review will be quite straightforward, as Medtronic is the fourth company to apply for a non-adjunctive CGM in the US – after Dexcom (G5, G6), Abbott (FreeStyle Libre 10- and 14-day), and Senseonics (Eversense 90-Day; obtained in June).

Medtronic told us it will not change the 670G’s software (in the pump or transmitter), though this label update would officially remove the need for a fingerstick before a food or correction bolus. At least two fingerstick calibrations per day will still be required for the sensor to function and keep 670G in Auto Mode.

Currently, FreeStyle Libre and Dexcom G5 are reimbursed by Medicare, with a G6 Medicare launch expected in 4Q19. Non-adjunctive Guardian Sensor 3 labeling will help the MiniMed 670G compete with the upcoming Tandem Control-IQ/Dexcom G6 hybrid closed loop system, which is expected to launch in 4Q19 as the first no-fingersticks hybrid closed loop. Presumably Tandem and Dexcom will obtain Medicare coverage for Control-IQ fairly quickly (or immediately?), though Tandem has not commented on this in recent calls.

Medtronic’s MiniMed 780G, targeted for launch by April 2020 and in its pivotal trial, will also rely on non-adjunctive use of Guardian Sensor 3, adding automated correction boluses, Bluetooth, software updating, and an ambitious time-in-range goal of >80%. Read more from our ADA coverage.

  • Medtronic’s next-gen CGM, Zeus, with day-one calibration, seven-day wear, and iCGM labeling, is currently recruiting for its pivotal trial (ClinicalTrials.gov page); primary completion is expected in February 2020. As of last month, FDA submission of Zeus was expected in April-October 2020, putting launch well after the 780G. Even with Zeus’ important improvements in the next 24 months, Medtronic will remain behind the current features of the factory-calibrated Dexcom G6 (10-day wear) and FreeStyle Libre (14-day wear, fully disposable).

 

--by Albert Cai, Adam Brown, and Kelly Close