Dive Brief:
- Medtronic has received 510(k) clearance for the use of its MiniMed 780G pump with two ultra-rapid-acting insulins and with a sensor made by Abbott, the company said Monday.
- The clearance, which the Food and Drug Administration issued in January, adds Novo Nordisk’s Fiasp and Eli Lilly’s Lyumjev to the list of insulins compatible with the pump.
- Medtronic disclosed the 510(k) alongside news that the FDA has cleared the 780G system for use with Instinct, a continuous glucose monitor made by Abbott, in people with Type 2 diabetes.
Dive Insight:
Medtronic said in May that it had filed multiple applications to expand the 780G label. The applications covered integration with a continuous glucose monitor based on Abbott’s platform, expanded labeling in Type 2 diabetes and use with the ultra-rapid-acting insulins Lyumjev, Fiasp and Merilog.
This week’s update revealed that the FDA has cleared the 780G system for use with the ultra-rapid-acting insulins Fiasp and Lyumjev. Sanofi’s Merilog is not named on the expanded label. MiniMed, Medtronic’s planned spinout, did not mention Merilog in the initial public offering paperwork it filed in January.
Medtronic said using 780G with Fiasp and Lyumjev could cut the impact of inexact carbohydrate counts and missed or delayed mealtime doses of insulin. The products act faster than other insulins to reduce the impact of late or missed meal doses. Medtronic said the clearance will allow individuals to choose the insulin that best matches their physiology and lifestyle.
The CGM clearance enables further integration with the Instinct sensor, a product that was the focus of a label expansion in September and a launch in December. Medtronic said the clearance covers the use of its SmartGuard algorithm as an interoperable automated glycemic controller and the 780G pump as an alternate controller enabled for insulin-requiring Type 2 diabetes.
Medicare and Medicare Advantage beneficiaries can now access MiniMed 780G with the Instinct sensor. Medtronic said customers who previously placed orders for the device combination will follow the standard Medicare billing and fulfillment process.
The company is offering Instinct alongside its Simplera Sync and Guardian 4 sensors. MiniMed warned in its IPO paperwork that Instinct could cause sales of Simplera and Guardian sensors to fall. The planned spinout also noted that while Instinct is based on Abbott’s most advanced single-analyte technology, the agreement does not cover dual glucose-ketone sensors that its partner is developing.
