Medtronic Receives FDA Approval for World's First Hybrid Closed Loop System for People with Type 1 Diabetes
September 28 2016 - 1:19PM
The MiniMed®
670G System Features the Company's Most Advanced
SmartGuard(TM) Algorithm To-Date
DUBLIN - Sept. 28, 2016 -
Medtronic plc (NYSE:MDT), the global leader in medical technology,
today announced it has received U.S. Food and Drug Administration
(FDA) approval of its MiniMed® 670G system - the first Hybrid
Closed Loop insulin delivery system
approved anywhere in the world. Featuring the company's most
advanced algorithm - SmartGuard(TM) HCL - the system is the latest
innovation in Medtronic's phased approach toward developing a fully
automated, closed loop system. Medtronic is committed to
simplifying and improving diabetes management through the
advancement of smart algorithms that achieve greater glucose
control with reduced patient input. Through SmartGuard HCL, the
system builds on Medtronic's industry leading algorithms to offer
therapy customization so patients and providers can choose from
increasing levels of automation that best fit their diabetes
management needs.
"With SmartGuard HCL, the ability to automate
basal insulin dosing 24 hours a day is a much-anticipated
advancement in the diabetes community for the profound impact it
may have on managing diabetes - particularly for minimizing glucose
variability and maximizing time in the target range," said Richard
M. Bergenstal, M.D., principal investigator of the pivotal study
and executive director of the Park Nicollet International Diabetes
Center in Minneapolis. "The data from the pivotal trial were
compelling and I am confident that this therapy will be
well-received by both the clinical and patient community."
"This significant milestone represents an
important step forward in the management of type 1 diabetes and
will improve the quality of life for those living with this chronic
disease," said Derek Rapp, president and CEO of JDRF, the leading
global organization funding type 1 diabetes research. "We are very
encouraged by the speed in which this groundbreaking technology was
approved by the FDA, and we are proud of the role JDRF played in
achieving this exciting breakthrough. Medtronic and JDRF are
committed to ensuring appropriate patient access to this
therapy."
The MiniMed 670G system features the Guardian®
Sensor, Medtronic's newest and most advanced glucose sensor with
enhanced accuracy and performance, and a longer 7-day
life. The Guardian Sensor, the first and only sensor approved
by the FDA to control a hybrid closed loop
system, incorporates diagnostic technology that continuously
monitors sensor health. Driven by the SmartGuard HCL, the
system delivers a variable rate of insulin 24 hours a day based on
the personalized needs of the patient, maximizing the time glucose
levels are within the target range. It is designed to learn what an
individual's insulin needs are and to take action to minimize both
high and low glucose levels. As a result, the system requires
minimal input - patients only need to enter mealtime carbohydrates,
accept bolus correction recommendations, and periodically calibrate
the sensor.
"The FDA approval of the world's first hybrid
closed loop system is a culmination of many years of hard work and
close collaboration with the clinical and patient communities to
generate the body of evidence needed to advance this technology for
those living with diabetes," said Francine Kaufman, M.D., chief
medical officer of the Diabetes Group at Medtronic. "We appreciate
the unprecedented speed by which the agency approved our PMA
submission to help bring this advanced insulin pump therapy so
quickly to U.S. patients living with this challenging disease. We
are committed to preparing for commercial launch as quickly as
possible while ensuring we provide the most successful rollout of
this novel therapy."
The system is approved for the treatment of people
with type 1 diabetes fourteen years of age and older with ongoing
studies to expand the indication to additional patient populations.
Medtronic will begin commercial release of the MiniMed 670G system
in the spring of 2017 with system availability increasing over
time. This timeline ensures payer coverage, market and
manufacturing readiness, as well as appropriate training of
employees, clinicians, educators and patients on the new system. As
the company moves toward initial commercial release and
subsequently to full production, users of the MiniMed 630G system
will be eligible for a Priority Access Program to the MiniMed 670G
system as their experience with our newest hardware platform will
facilitate an optimal transition. Regulatory approval of the
MiniMed 670G is expected outside of the U.S. in the summer of 2017.
More details can be found at
http://www.medtronicdiabetes.com/products/priority-access.
MiniMed® 670G
System
Click the thumbnail above for a larger
image.
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 Medtronic
Medtronic 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 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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.
-end-
Contacts:
Janet Kim
Public Relations
+1-818-576-5014
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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