Medtronic, Inc. (NYSE: MDT) announces the launch of Enlite? Sensor, the
newest and most advanced glucose sensor for continuous glucose
monitoring (CGM), in more than 35 countries outside of the United
States. CGM has been shown in multiple landmark clinical studies to help
diabetes patients achieve better glucose control without increasing
hypoglycemia (low blood sugar), a dangerous and potentially
life-threatening complication of diabetes. The Enlite Sensor combines
greater comfort with improved glucose sensor performance in both overall
accuracy1 and hypo detection2.
When the Enlite Sensor is used with the predictive alerts feature on
Medtronic systems, diabetes patients have access to hypo detection rates
up to 98%.3 This helps give early warning to people with
diabetes so they can take action to prevent dangerous hypoglycemia,
which is one of the major concerns of people living with diabetes.
"The Enlite Sensor will improve patients' ability to predict and detect
hypoglycemia, which can be one of the most frightening aspects of living
with Type 1 diabetes," Emanuele Bosi, professor of Endocrinology, Head
of the Department of Internal Medicine, San Raffaele Scientific
Institute and San Raffaele Vita Salute University. "CGM is an important
element in managing diabetes. The STAR 3 trial demonstrated that
diabetes patients achieved better glucose control when sensors were
integrated with insulin pump therapy compared to multiple daily
injections. Moreover, other recent studies continue to suggest that the
more often patients use CGM, the greater average glucose control they
can achieve without increasing hypoglycemia."
Significant design improvements make Enlite Sensor more comfortable and
easier to use than the previous sensor. In a clinical study of Enlite
Sensor, 85% of patients agreed that sensor insertion was pain free and
86% agreed that the Enlite insertion device was easy to use4.
The Enlite Sensor is a significantly smaller sensor compared to
Medtronic's previous product --69% smaller in sensor size by volume, 38%
shorter in length.5 Adding to patient convenience, the Enlite
Sensor can be worn on the abdomen and buttocks and used for up to six
"The adoption of CGM is growing rapidly, as both diabetes patients and
their diabetes care professionals experience the benefits of seeing
fluctuations in glucose patterns so that action can be taken to achieve
better diabetes control. By making the new Enlite Sensor smaller, as
well as easier to insert and wear, we expect that more people with
diabetes will be able to utilize this technology to manage their
condition and ultimately improve their lives," said Katie Szyman,
president of the Diabetes business and senior vice president at
The Enlite Sensor received CE (Conformité Européenne) Mark
approval in Paris, France and is being launched subject to other local
approvals in more than 35 countries. Medtronic is working closely with
the U.S. Food and Drug Administration on plans to commercialize the
product in the United States. The Enlite Sensor is labeled for use with:
MiniMed Paradigm® REAL-Time System, MiniMed Paradigm Veo?
System, Guardian® REAL-Time Continuous Glucose Monitoring System, and
About Continuous Glucose Monitoring (CGM)
use Personal CGM for the continuous measurement of glucose levels in the
interstitial fluid (fluid found between the cells) of subcutaneous
tissue. The patient inserts a disposable, needle-like sensor under the
skin and the sensor transmits glucose data every five minutes to a
monitor. Professional CGM is a clinician-owned device that records
glucose data without patient interaction for retrospective review. CGM
provides a more complete picture because it reveals high and low glucose
levels that periodic fingerstick testing might miss. The landmark
clinical study STAR 3 showed that patients using insulin pump therapy
integrated with CGM achieved a reduction in mean A1C that was four times
greater than patients using multiple daily injections.6
In 2010, the American Association of Clinical Endocrinologists (AACE)
released a consensus statement on continuous glucose monitoring which
stated "CGM technology is not only novel, but it can improve the lives
of patients who incorporate it into a comprehensive diabetes management
plan."7 The statement recommends CGM particularly for
children, adolescents and adults with frequent hypoglycemia or
hypoglycemia unawareness, A1C levels over their target, large
variability in glycemic levels, and the need to lower A1C levels without
increasing hypoglycemic events, as well as for those who are pregnant or
are planning to become pregnant.
About the Diabetes Business at Medtronic
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 results.
1 While accuracy improved with all Medtronic systems, exact
data varies depending upon the system the sensor is used with. In a
home-use study of adult patients, Enlite Sensor's MARD was found to be
15.3% vs. 18.4% with SofSensor. MARD is the Mean Absolute Relative
Difference which is a measure of average variation of sensor readings
compared to Yellow Springs Instruments blood glucose analyzer reference
machine readings. The lower the MARD value, the more accurate the sensor.
Hypoglycemia detection is the percent of time that Medtronic's CGM
device correctly alerts a patient to a glucose level that is less than
3.89 mmol/L within ±30 minutes of the low glucose event occurring (when
predictive alert is set to 30 minutes).
3 This refers to
a +/- 30 minute event analysis. Low limit set at 3.89 mmol/L and low
predictive alert set at 30 minutes. Source: Enlite Sensor Performance
Addendum (for 522/722, 524/724 and Guardian)
4 Data on
5 Data on file
6 (0.8% for SAP vs.
0.2% for MDI) (p<0.001).
7 American Association of
Clinical Endocrinologists CGM Task Force. Consensus Statement:
Continuous Glucose Monitoring. Endocrine Practice. Sept/Oct 2010; Vol
16, No 5, pp 730 - 744.