Medtronic Receives FDA Approval for Guardian Connect Continuous Glucose Monitoring (CGM) System for People Living with Diabetes
March 12 2018 - 10:26AM
'Smart' CGM
System Provides Predictive Alerts for Dangerous Sensor Glucose
Levels;
Exclusive Access to Sugar.IQ Assistant with
Watson Offers More Proactive Diabetes Management
DUBLIN - March 12, 2018 -
Medtronic plc (NYSE:MDT), the global leader in medical technology,
services and solutions, today announced it received U.S. Food and
Drug Administration (FDA) approval for its Guardian(TM) Connect
continuous glucose monitoring (CGM) system, for people with
diabetes ages 14 to 75 years. The Guardian Connect system is the
first smart standalone CGM system1 to help
people with diabetes stay ahead of high and low glucose events. The
Guardian Connect system empowers people using multiple daily
injections (MDI) to more proactively manage their diabetes.
Featuring our latest predictive algorithms in
diabetes care, the Guardian Connect system is the only standalone
CGM system that can alert patients of potential high or low glucose
events up to 60 minutes in advance. Using Guardian(TM) Sensor 3,
the most advanced glucose sensor from Medtronic and the only sensor
trusted to power a hybrid closed loop system, the Guardian Connect
system was proven in a clinical study to accurately alert patients
of 98.5 percent of hypoglycemic events2. Care
partners can use the system to stay more informed about their loved
ones with diabetes as well by tracking glucose in real-time or
receiving text alerts.
People using the Guardian Connect system will also
have exclusive access to the groundbreaking Sugar.IQ(TM) smart
diabetes assistant, empowering them to further address the daily
challenges of diabetes. With artificial intelligence technology
from IBM Watson Health, the Sugar.IQ assistant continually analyzes
how an individual's glucose levels respond to their food intake,
insulin dosages, daily routines, and other factors3. Together
with the Guardian Connect system, the Sugar.IQ assistant can turn
difficult-to-determine patterns into personalized, actionable
insights that help people with diabetes keep glucose levels in
their target range.
"Despite proven benefits and advances in technology, only a
minority of insulin-using people with diabetes currently use
continuous glucose monitors (CGM)" said Dr. Timothy Bailey,
director of the AMCR Institute and clinical associate professor,
University of California, San Diego. "Newer sensors paired with
intelligent algorithms that help to both predict and understand
glucose excursions, particularly hypoglycemia, will make diabetes
safer and more comprehensible for people who inject insulin.
Greater utilization of smarter CGM systems promises to allow our
patients to achieve more glycemic time-in-range and to further
reduce the risk of hypoglycemia."
"The FDA approval of the Guardian Connect system
fills a key gap that exists in diabetes treatment today - how to
predict dangerous glucose highs and lows so they can be potentially
avoided," said Annette Brüls, president, Diabetes Service and
Solutions at Medtronic. "With predictive alerts and the Sugar.IQ
assistant, the Guardian(TM) Connect system enables people to
proactively manage their diabetes, so they can focus on living
their life, not constantly worrying about their glucose
levels."
The Guardian Connect system will be available in
the first quarter of Medtronic's fiscal year 2019 (May 2018 - July
2018) for people with diabetes who are looking to take on a more
proactive role in managing their diabetes.
About Continuous Glucose
Monitoring (CGM)
A CGM system provides continuous, real-time glucose value and trend
information about glucose levels for people with diabetes. In
addition, a smart CGM system predicts future high and low glucose
events and provides access to additional algorithms and insights
that can inform users of clinically relevant glucose patterns. This
allows for appropriate intervention (after verifying with a blood
fingerstick test) to mitigate hyperglycemia (high blood glucose) or
hypoglycemia (low blood glucose), increasing the patient's time in
the optimal glucose target range. To use a CGM system, the person
with diabetes inserts a tiny sensor beneath the skin, in the
abdomen or upper arm. The sensor, which measures glucose levels
from the interstitial fluid under the skin, is attached to a
transmitter that sends readings to an app, wearable monitor or
insulin pump every five minutes. Alerts can be customized to notify
patients up to 60 minutes before they reach personal preset low or
high sensor glucose limits. CGM provides a more complete picture
because it reveals high and low glucose levels that periodic blood
fingerstick testing might miss.
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 84,000 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-
1 Smart
CGM predicts future high and low sensor glucose events and provides
access to additional algorithms and insights that can inform users
of clinically relevant glucose patterns.
2 Guardian
Connect system Instructions for Use (IFU). With a sensor glucose
limit of 70 mg/dL, with calibration every 12 hours, both predictive
and threshold alerts "On," within 30 minutes; abdomen sensor
insertion. The correct detection rate for arm inserted sensor is
96.7 percent; with the same settings and conditions.
3 Based on
information provided by the user.
Contacts:
Pamela Reese
Public Relations
+1-818-576-3398
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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