Medtronic (NYSE:MDT) announced that it received FDA approval for its MiniMed 780G system with the Guardian 4 sensor.
The news — posted in the evening on April 21 — has MDT shares up more than 4% to $89.36 apiece in afternoon trading today. (MassDevice’s MedTech 100 Index is up slightly.) The positive news for the business unit follows some challenges in recent years. Analysts also reacted well to the news, as Wells Fargo and Barclays upgraded MDT stock.
The MiniMed 780G features the latest Guardian 4 technology, requiring no fingersticks while in SmartGuard mode. The approval makes it the only system with meal detection technology providing automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.
MiniMed 780G with Guardian 4 offers insulin to account for when users forget to bolus or underestimate the number of carbs in their meal.
“Mealtimes prove to be one of the biggest challenges for people living with type 1 diabetes and now for the first time, the MiniMed 780G system addresses this unmet need with automatic, real-time insulin corrections,” said Que Dallara, EVP and president of Medtronic Diabetes. “A lot can happen to blood sugars in the span of an hour or even just a few minutes, so we’ve designed our system for real life – the algorithm adapts to the user and helps compensate for everyday challenges that are quite common around mealtimes. We built in features informed by extensive customer feedback and we’re excited to deliver a system with ease of use at the forefront.”
FDA approval covers users seven years old and above with type 1 diabetes. Medtronic plans to begin taking pre-orders on May 15, 2023. It expects the first shipments to come in the summer.
Users of the MiniMed 770G system can upgrade to 780G through a no-cost, remote software upgrade.
Features of the Medtronic MiniMed 780G with Guardian 4
MiniMed780G features glucose target settings as low as 100 mg/dL. That marks the lowest in any automated insulin pump on the market, the company said. It also closely mirrors the average glucose of someone not living with diabetes.
This setting enables the pump to “treat to target,” automatically delivering basal insulin adjustments and autocorrections to a set target. Medtronic said it also represents the only pump with an infusion set capable of a wear time of up to seven days. The company launched this infusion set — which doubles the previous wear time — in November 2022.
It also features advanced materials to help reduce insulin preservation loss and maintain insulin flow and stability. This results in a reduced risk of infusion set occlusion.
Combined with Guardian 4, MiniMed 780G offers a user-friendly design, according to Medtronic. The company says 94% of users report satisfaction with the impact the system has on their quality of life. Users also reported remaining in SmartGuard technology mode 95% of the time.
“My last two years on the MiniMed 780G system as part of the clinical trial have been incredible for me,” said Terry Weland, a Medtronic customer of 25 years. “The system is so easy to use. I don’t know anyone who’s perfect at carb counting and there are times when you’re not as on top of things as you’d like to be. I don’t stress over my diabetes like I used to because I know the system has my back.
Weland added that the ability to sync the sensor and infusion set changes to every seven says streamlines the diabetes management routine.
Backed by clinical data
Within the last year, multiple sets of clinical data supported the use of the Medtronic MiniMed 780G.
In April of last year, new data demonstrated sustained improvements in glycemic outcomes. These met or exceeded consensus guideline recommendations of 70% time in range. Medtronic also reported less user interaction and fewer fingerstick calibrations.
Real-world analyses shared in June 2022 saw the advanced hybrid closed loop system further demonstrate improvements in glycemic outcomes that met consensus guideline recommendation of 70% time in range with less user interaction.
In September, Medtronic reported data from the ADAPT study that again demonstrated improved glycemic control and treatment satisfaction among users of MiniMed 780G. Users of MiniMed 780G also saw a 27.6% increase in time in range. That amounted to 6.6 more hours per day in target range compared to standard of care. Users also saw no increase in time in hypoglycemia. The improvement proved even greater overnight with the algorithm in full control.
Finally, in February, more ADAPT data showed a 1.4% reduction in HbA1C for MiniMed 780G users. The data also demonstrated an overnight time in range increase of 30.2%. At the close of the six-month study period, all participants in a comparative multiple daily injection/CGM group crossed over to MiniMed 780G.
Challenging times for Medtronic
Medtronic has long been reporting positive news around its next-generation technology. However, the future of its diabetes business remains cloudy.
An FDA warning letter in 2021 highlighted inadequacies in specific medical device quality system requirements at the Medtronic Diabetes business’ Northridge, California, facility. CEO Geoff Martha said early in 2022 that the letter was likely to impact the regulatory timelines for MiniMed 780G with Guardian 4. The company said last fall that it achieved 90% of the FDA’s action items.
Amid the effort to allay the FDA’s concerns, analysts began suggesting that the Medtronic Diabetes business was on the spinoff block. In April 2022, Mike Matson, David Saxon and Joseph Conway of Needham published a report singling out the diabetes and spine businesses as possible spinoff options for Medtronic. However, that looks less likely at the moment as the company currently has plans to sell off its Patient Monitoring and Respiratory Interventions businesses. It also officially spun off its kidney care unit at the start of the month.
Meanwhile, the company’s overall business faces uncertainty. Earlier this week, Medtronic began laying off workers in earnest. Martha said layoffs would take place over the coming months, with impact varying by team, region and country.
The move came as Medtronic promised “significant expense reductions” in the final quarter of its fiscal year, which ends on April 28. The company also has plans to close a Sunnyvale, California facility, transferring the radio-frequency-ablation catheter manufacturing at the site to Ireland as it lays off 59 workers.
This story originally ran on April 21, 2023. Updated April 24 with reaction from investors and analysts.