MiniMed 780G (insulin pump)

2020: Medtronic hid problems in the device from investors

In mid-September 2022, investors blamed Medtronic the company for failing to disclose information problems in its insulin pump business, leading to a delay in the release of a product previously considered a source of growth.

The lawsuit concerns investors who bought Medtronic shares between June 8, 2019 and May 25, 2022. That period lasts from when the company announced the start of the main MiniMed 780G trial to when the company said it expects sales to fall 6% -7% in fiscal 2023. Medtronic's forecast for 2023 suggested a lack of 780G sales in the United States, which was done after a warning letter from the FDA.

Medtronic has long hidden problems in insulin pumps

Throughout the period, Medtronic extolled the 780G 's prospects, for example, saying it was very close to the launch phase and all regulatory deadlines were met in early 2020 despite problems in the broader insulin pump business, the plaintiffs said.

The problems initially concerned older devices, such as some MiniMed 630G and 670G pumps, which were the subject of a Class I recall notice in early 2020. However, the situation escalated at the end of 2021, when Medtronic released a warning letter related to the insulin pump facility and uncertainty about the timing of approval of diabetes products in the United States.

Based in particular on the warning letter, the plaintiffs allege Medtronic failed to disclose that its product quality control systems were inadequate. And that it did not comply with regulatory requirements regarding risk assessment, corrective and preventive actions, complaints handling, device recalls, and adverse event reporting. The plaintiffs allege the company was aware of the problems when it advertised the 780G.

Medtronic's share price fell about 6% in response to the warning letter and by the same amount when the company issued its guidance for fiscal 2023. The plaintiffs allege that investors suffered losses when information that was allegedly hidden from the market became public.^[1]

2020: MiniMed 780G announcement

In mid-June 2020, Medtronic released a new generation insulin pump. A model called MiniMed 780G is pre-sanzachen for the treatment of type 1 diabetes mellitus in people aged 7 to 80 years.

Using the company's most advanced algorithm, SmartGuard, the new system automates the delivery of both basal insulin and corrective boluses every five minutes. The MiniMed 780G system allows you to personalize the target glucose level to 100 mg/dL (5.5 mmol/L), that is, lower than any other closed-loop hybrid system, and is designed to stabilize blood sugar levels.

Medtronic launches next-generation insulin pump MiniMed 780G

We wanted to develop a system that would simplify the management of diabetes mellitus, "explained Sean Salmon, Executive Vice President and President of the Diabetes Group at Medtronic. - Typically, the patient needs to calculate the carbohydrate intake before each snack or meal to inject the desired volume of insulin. This system will correct for errors in calculations or missed doses of the drug using an algorithm that automatically adjusts glucose levels.

According to patients who participated in the clinical trial, the MiniMed 780G system "made living with diabetes and controlling the disease much easier." The MiniMed 780G system is designed to make use as easy as possible, including reducing the amount of information entered by the patient. In addition, the MiniMed 780G system allows users and healthcare providers to monitor glucose levels in real time on iOS and Android smartphones through dedicated apps.

Deliveries of the new system are expected to begin in the fall of 2020 in some European countries. In the United States, the MiniMed 780G system can only be used for research purposes and is not approved for sale.^[2]

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