2013-09-27 14:33:02 -
MiniMed(®) 530G with Enlite(®) Automatically Stops Insulin Delivery If Sensor
Glucose Levels Fall Below a Predetermined Threshold
MINNEAPOLIS - September 27, 2013 -Medtronic, Inc. (NYSE:MDT) today announced the
U.S. Food and Drug Administration (FDA) approval of the MiniMed(®) 530G with
Enlite(®), a breakthrough, first-generation artificial pancreas system with
Threshold Suspend automation for people with diabetes. Medtronic's system is
the first in the United States that can automatically stop insulin delivery when
sensor glucose values reach a preset level and when the patient doesn't respond
to the Threshold Suspend alarm. The MiniMed 530G system incorporates the new
Enlite sensor, Medtronic's most accurate and comfortable continuous glucose
sensor with a 31 percent improvement in overall accuracy from the
"The diabetes community has eagerly awaited approval of this system that stops
insulin delivery when sensor glucose values fall below a predetermined
threshold," said Richard M. Bergenstal, M.D., executive director of the
International Diabetes Center at Park Nicollet Health Services in Minneapolis
and Clinical Professor for the Department of Medicine at the University of
Minnesota. "We are hopeful that advances such as this and improvements in the
accuracy of continuous glucose sensors will help people with diabetes strive for
better control of their diabetes."
"We're excited to bring yet another important 'first' to the United States.
MiniMed 530G with Enlite can help people gain better control of their diabetes
versus multiple daily injections," said Katie Szyman, president of the Diabetes
business at Medtronic. "We are committed to advancing closed loop algorithms,
continuous glucose monitoring and insulin delivery technologies to bring new
artificial pancreas systems to market."
The Enlite sensor delivers better comfort and reliable CGM accuracy. In
addition to the 31 percent improvement in overall accuracy, the Enlite sensor
detects up to 93 percent of hypoglycemia episodes when predictive and threshold
alerts are on.[ii] The Enlite sensor is also 69 percent smaller[iii] than the
previous Medtronic sensor, to deliver improved comfort in using continuous
glucose monitoring. The new Enlite serter provides a simpler sensor insertion
process with a hidden-introducer needle.
The MiniMed 530G system was approved for use by people with diabetes ages 16 and
older. Medtronic will conduct a post-approval study including children ages two
and older. The Enlite sensor can be worn for six days.
As a condition of approval, in addition to the post-approval study, Medtronic
will engage in direct patient follow up and will make certain manufacturing
accommodations. These commitments are consistent with the product approval by
the FDA and an accompanying warning letter issued to Medtronic on Sept.
19, 2013. Medtronic has already addressed many of the observations noted in the
warning letter and is committed to resolving the remaining observations as
quickly as possible and in accordance with the product approval requirements.
Medtronic is committed to providing safe and effective products for people with
Medtronic will begin ramping up production immediately to prepare for a launch
of the MiniMed 530G in the next several weeks. In the meantime, customers can
find additional product and important safety information at
Artificial Pancreas System with Threshold Suspend Automation
The MiniMed 530G system is the first system approved under the new product
classification, "OZO: Artificial Pancreas Device System, Threshold Suspend,"
created by the U.S. Food and Drug Administration. Threshold Suspend automation
automatically stops the delivery of insulin if glucose levels reach a threshold,
which can be set by a healthcare provider between 60-90 mg/dL. Once the
threshold is met, the MiniMed 530G system will first alert the wearer with an
alarm. If the individual is sleeping, unconscious or otherwise unable to react,
the system will suspend all insulin delivery for two hours. Insulin delivery can
be resumed at any time.
When Medtronic develops a next generation product for diabetes control, it will
be designed to fully replicate the function of the pancreas by automatically
monitoring glucose levels and delivering appropriate insulin to people with Type
1 diabetes; this future "fully automated artificial pancreas" will truly require
minimal to no interaction by the patient user.
A multimedia version of this release, with downloadable graphics, can be found
About the Diabetes Business at Medtronic
The Diabetes business at Medtronic (www.medtronicdiabetes.com) is the world
leader in advanced diabetes management solutions, including integrated diabetes
management systems, insulin pump therapy, continuous glucose monitoring systems
and therapy management software, as well as world-class, 24/7 expert consumer
and professional service and support.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health and extending
life for millions of people around the world.
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
[i]MiniMed Paradigm REAL-Time Revel with Sof-sensor User Guide and Enlite(®).
[ii]MiniMed 530G user guide. This refers to a +/- 30 minute event analysis. Low
limit set at 70 mg/dL and low predictive alert set at 30 minutes. The false
alert rate was 33% using the same analysis.
[iii]According to the MiniMed Paradigm REAL-Time Revel User Guide and MiniMed
530G User Guide
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Medtronic, Inc. via Thomson Reuters ONE