With CE Mark approval, the benefits of the
MiniMed™ 780G system are now available with a new sensor that takes
less than 10 seconds to insert1
DUBLIN, Jan. 8, 2024
/PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in
healthcare technology, today announced CE (Conformité Européenne)
Mark approval for the MiniMed™ 780G system with Simplera Sync™, a
disposable, all-in-one continuous glucose monitor (CGM) requiring
no fingersticks or overtape. Simplera Sync™ features an improved
user experience with a simple, two-step insertion process and is
half the size of previous Medtronic sensors.*
The MiniMed 780G system with Simplera Sync™ sensor will be
available in Europe via limited
release in spring 2024. Medtronic will begin the phased commercial
launch in Europe in the summer of
2024. Today, the MiniMed™ 780G system can be used with the
Guardian™ 4 sensor.
The MiniMed™ 780G system is Medtronic's most advanced insulin
delivery system, automatically adjusting and
correcting† glucose levels every 5
minutes.§ It's the world's only system with a Meal
Detection™ feature‡ that is designed to reduce
post-meal hyperglycemia when users occasionally forget to give
themselves insulin or underestimate the number of carbs in their
snacks or meal. The system, which is available with the world's
only 7-day infusion set, also features one of the lowest glucose
target settings (as low as 100 mg/dL) of any automated insulin
delivery system. With this "treat to target" approach, the system
more closely mirrors the glucose levels of someone not living with
diabetes. With both Simplera Sync™ sensor and the Guardian™ 4
sensor, no fingersticks are required.**
"A challenging aspect of living with diabetes is counting
carbohydrates and dosing the right amount of insulin before
consuming snacks and meals. Many people underestimate their carbs,
which can lead to high blood sugars (hyperglycemia). Prolonged
hyperglycemia can lead to serious health problems impacting the
eyes, major organs, and even cognitive function, which is
particularly concerning in developing children," Robert Vigersky,
M.D., Chief Medical Officer, Medtronic Diabetes, Professor of
Medicine, Uniformed Services University of the
Health Sciences "With its responsive algorithm, the MiniMed™
780G system can help people living with diabetes even when they
occasionally forget to bolus or undercount their carbs. The system
takes on more of the work involved in diabetes management and helps
alleviate mental burden."
"We're incredibly proud that the MiniMed™ 780G system continues
to be the most widely used automated insulin delivery system in
Europe since we launched it in
2020. Real-world data on over 100,000 users on the system across
many geographies and cultures shows that when using recommended
settings the system is delivering an average Time in Range of
nearly 80%, raising the bar on what 'good' looks like2,"
said Que Dallara, EVP and President, Medtronic Diabetes. "With the
introduction of Simplera Sync™ sensor, we're able to offer the
proven benefits of our MiniMed™ 780G system with our newest
and most comfortable sensor that can be applied in under 10
seconds."
The MiniMed™ 780G system with Simplera Sync™ sensor is
indicated for ages 7+ and compatible with iOS and Android. Simplera
Sync™ sensor is not approved by the FDA and is limited to
investigational use in the U.S.
Simplera Sync™ sensor is designed to leverage Medtronic's
advanced AID algorithm as part of its MiniMed™ 780G system while
having a similar look and feel as the Simplera™ CGM. The
Simplera™ CGM for integrated use with the InPen™ smart insulin
pen received CE Mark in September
2023.
About the Diabetes Business at Medtronic
(www.medtronicdiabetes.com)
Medtronic Diabetes is on a mission to alleviate the burden of
diabetes by empowering individuals to live life on their terms,
with the most advanced diabetes technology and always-on support
when and how they need it. We've pioneered first-of-its-kind
innovations for over 40 years and are committed to designing the
future of diabetes management through next-generation sensors
(CGM), intelligent dosing systems, and the power of data science
and AI while always putting the customer experience at the
forefront.
About Medtronic
Bold thinking. Bolder actions. We are
Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global
healthcare technology company that boldly attacks the most
challenging health problems facing humanity by searching out and
finding solutions. Our Mission — to alleviate pain, restore health,
and extend life — unites a global team of 90,000+ passionate people
across more than 150 countries. Our technologies and therapies
treat 70 health conditions and include cardiac devices, surgical
robotics, insulin pumps, surgical tools, patient monitoring
systems, and more. Powered by our diverse knowledge, insatiable
curiosity, and desire to help all those who need it, we deliver
innovative technologies that transform the lives of two people
every second, every hour, every day. Expect more from us as we
empower insight-driven care, experiences that put people first, and
better outcomes for our world. In everything we do, we are
engineering the extraordinary. For more information on Medtronic
(NYSE:MDT), visit www.Medtronic.com and follow
@Medtronic on Twitter and LinkedIn.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
1. Data on file, CIP330 Evaluation of Updated Continuous Glucose
Monitoring (CGM) Form Factor in Adults, Adolescents and
Pediatrics.
2. Choudhary, Arrieta, van den Heuvel, Castaneda, Smaniotto, Cohen.
Celebrating the data from 100,000 real-world users of the MiniMed
780G system in Europe,
Middle East and Africa collected over 3 years: from data to
clinical evidence. DTT Epub ahead of print. Doi:
10.1089/dia.2023.0433
*Participants in a clinical trial reported the sensor was
smaller and lighter than other sensors they have used. Data on
file: CIP330, N=243, ages 2-80.
†Refers to auto correct,
which provides bolus assistance. Can deliver all correction doses
automatically without user interaction, feature can be turned on
and off.
‡Taking a bolus 15 – 20 minutes before a meal helps to keep blood
sugar levels under control after eating.
§ Refers to SmartGuard™ feature. Individual results may vary.
**A blood glucose (BG) reading is needed when entering
SmartGuard™ feature. If glucose alerts and CGM readings do not
match your symptoms, use a BG meter to make diabetes treatment
decisions. Refer to System User Guide – SmartGuard™ feature.
Some user interaction required.
Media Kit:
https://news.medtronic.com/MiniMed-TM-780G-System-with-Simplera-Sync-TM
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SOURCE Medtronic plc