Medtronic Secures CE Mark for MiniMed™ 780G Advanced Hybrid Closed Loop System Designed to Further Simplify Type 1 Diabetes...
June 11 2020 - 9:00AM
Medtronic plc (NYSE:MDT), the global leader in medical
technology, today announced CE (Conformité Européenne) Marking of
its MiniMed™ 780G system, a next generation closed loop insulin
pump system for the treatment of type 1 diabetes in people age 7 to
80 years. Leveraging the company’s most advanced SmartGuard™
algorithm, the system automates the delivery of both basal insulin
and correction boluses every five minutes to help people with
diabetes avoid highs and lows with greater ease. The MiniMed 780G
system enables the personalization of glucose goals with an
adjustable target setting as low as 100 mg/dL (5.5 mmol/L) — lower
than any other advanced hybrid closed loop system — and is
designed to help stabilize blood sugar levels and further improve
glucose control.
“We wanted to design a system that further
simplifies diabetes management and adapts to people’s life
with the goal of enhancing their experience in a seamless way,”
said Sean Salmon, Executive Vice President and President of the
Diabetes Group at Medtronic. “We know it can be challenging to have
to calculate carbohydrate intake before every snack or meal on a
daily basis to ensure the right amount of insulin is
dosed. With this system, users will have an extra layer of
coverage for those times they miscalculate their carbs or forget to
pre-bolus with analgorithm that automatically corrects for
high glucose when needed. We want to help people spend more
time living their life and less time worrying about their diabetes
management — we’re confident this system delivers on that important
goal.”
Patients who participated in the clinical study
provided feedback that the MiniMed 780G system “made life with
diabetes and control so much easier” and that it made “life
significantly easier.”
In addition to the automated algorithm which
includes technology from DreaMed Diabetes, the MiniMed 780G system
was designed to be easy to use by requiring less input from the
user1. With the addition of Bluetooth® connectivity, the
MiniMed 780G system will enable users and their care partners to
see real-time glucose data and trends on compatible iOS and Android
smartphones via apps. Additionally, healthcare providers will
find that managing patients on the system is simple as there are
only a few settings that need adjustment to enable optimal use of
the technology.
“I am incredibly proud of the strong collaboration
that resulted in this meaningful step forward with the MiniMed 780G
system, which the clinical trial has demonstrated to be a
beneficial tool for a wide range of patients and particularly
adolescents,” said Professor Moshe Phillip, director of the
Institute for Endocrinology and Diabetes, National Center of
Childhood Diabetes, Schneider Children’s Medical Center of Israel,
co-founder and chief science officer, DreaMed Diabetes. “By
continuing to increase the automation of insulin pump systems, we
can further reduce burden for people living with diabetes while
simultaneously driving positive clinical outcomes.”
The system is expected to begin shipping this
Fall in select countries in Europe. In the United States, the
MiniMed 780G system is investigational use only and not approved
for sale.
The data from three trials using the next
generation advanced hybrid closed loop system from Medtronic will
be presented in a symposium at the virtual 80th Scientific
Sessions of the American Diabetes Association.
- Symposium: The Next Generation of Automated Insulin
Delivery Systems for Persons with Type 1 Diabetes – Four New
Clinical Trials
- June 12, 2:00 – 4:00 pm (CDT)
The MiniMed 780G system is part of the new
Medtronic portfolio of insulin pumps with smartphone
connectivityvia Bluetooth. Additional systems with CE Mark include
the MiniMed™ 770G2 system which uses the same hybrid closed
loop technology as the current MiniMed™ 670G system that is
available in many parts of the world. There is also a MiniMed™
720G3 system with CE Mark that provides readings from a
Medtronic glucose sensor without automating any insulin delivery
based off those readings. These MiniMed™ 700 series pumps will be
made available in countries around the world based on local
market approvals and regulations.
About the Diabetes Group at
Medtronic (www.medtronicdiabetes.com)Medtronic
is working together with the global community to change the way
people manage diabetes. The company aims to transform diabetes care
by expanding access, integrating care and improving outcomes, so
people living with diabetes can enjoy greater freedom and better
health.
About MedtronicMedtronic plc
(www.medtronic.com), headquartered in Dublin, Ireland, is among the
world's largest medical technology, services and solutions
companies - alleviating pain, restoring health and extending life
for millions of people around the world. Medtronic employs more
than 90,000 people worldwide, serving physicians, hospitals and
patients in more than 150 countries. The company is focused on
collaborating with stakeholders around the world to take healthcare
Further, Together.
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.
Android is a trademark of Google LLC.
The Bluetooth word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc. and any use of such marks
by Medtronic is under license.
-end-
1 When the MiniMed 780G system is not using
the SmartGuard feature, pump functions are operating in manual
mode. In manual mode, the sensor glucose readings from Guardian™
Sensor 3 are not intended to be used directly for making therapy
adjustments, but rather to provide an indication of when a finger
stick/BG meter reading may be required. All therapy adjustments
should be based on measurements obtained using a home glucose
monitor and not on values provided by the Guardian™ Sensor 3 in
manual mode.
2 Not approved for commercial distribution in
the United States.
3 Not approved for commercial distribution in
the United States.
Pamela ReesePublic Relations+1-818-576-3398
Ryan WeispfenningInvestor Relations+1-763-505-4626
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