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Medtronic Secures Two CE Mark Approvals for Guardian 4 Sensor & for InPen MDI Smart Insulin Pen

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced CE (Conformité Européenne) Mark for expanded functionality of the company’s InPen™ smart2 insulin pen for multiple daily injections (MDI). The company also announced CE Mark for its Guardian™ 4 sensor, which requires no fingersticks for calibration or diabetes treatment decisions.

The CE Mark allows this next-generation sensor to be integrated with either the MiniMed™ 780G insulin pump system or InPen, or for stand-alone continuous glucose monitoring (CGM) use. These latest innovations will begin commercial launches in European markets later this Fall (Q2 FY22).

“We look forward to having multiple ways to help our patients manage their diabetes as we know that patient needs and preferences can vary greatly,” said Prof. Goran Petrovski, M.D., MSc, Ph.D., diabetologist, Endocrinology Unit, Sidra Medicine, Doha, Qatar. “Living with diabetes is challenging, and these innovations are finding new ways to reduce the work that people must do every day to stay healthy.”

The InPen is the first and only smart insulin pen approved in Europe that’s integrated with real-time CGM via one convenient smartphone app. The smart MDI system automatically records insulin doses, tracks active insulin, and recommends mealtime and correction doses based on an auto-populated bolus calculator. By combining InPen with the Guardian 4 CGM system, it will provide real-time glucose readings and alerts alongside insulin dose information giving users everything they need to manage their diabetes in one place. Rather than switching between apps, users will have the ability to see all their information in real-time, in one view — making it easier to make informed dosing decisions to manage their glucose levels. Combined insulin dose and glucose reports can be easily shared with care partners and healthcare professionals as well.

For individuals who prefer automated insulin delivery via an insulin pump, the MiniMed 780G system with Guardian 4 sensor will automatically adjust and correct insulin delivery every 5 minutes with no fingersticks. By pairing the MiniMed 780G system with the recently launched Medtronic Extended infusion set that is indicated for up to 7 days, twice as long as current infusion sets, insulin pump users may need to perform 70 fewer set changes per year. With these two innovations, Medtronic offers the only pump that adjusts and corrects every 5 minutes with an infusion set that lasts twice as long –improving the experience of using insulin pump therapy.

“We know that diabetes is a very personal journey, and we want to meet people where they are with solutions that fit their lifestyle and needs while enabling them to experience seamless support through all their life transitions. That’s why we’ve made the commitment to expand our portfolio and prioritize what matters most to our customers — a technology experience that’s easy but doesn’t compromise the outcomes they deliver,” said Sean Salmon, executive vice president and president of the Diabetes business at Medtronic. “We’re pleased to enhance the customer experience through these advancements and look forward to delivering a strong cadence of innovations to eliminate the burden of constant decision making that people with diabetes carry on a daily basis.”

In the United States, Guardian 4 sensor and the MiniMed 780G system are investigational use only and not approved for sale.

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