Medtronic Sentrino® CGM System Gains CE Mark
2012-12-03 15:04:57 -
System Designed to Improve Glucose Control in Critical Care Patients
MINNEAPOLIS - December 3, 2012 - Medtronic, Inc. (NYSE:MDT) today announced CE
(Conformité Européenne) Mark approval of its innovative Sentrino® Continuous
Glucose Management System, the first minimally invasive continuous glucose
monitoring (CGM) system specifically designed for use in hospital critical care
units (CCU). The Sentrino CGM System provides real-time trend data that serves
as an early warning system, allowing clinicians to appropriately intervene to
prevent glycemic excursions and maximize the patient's time in the target
range. In addition, the system integrates simply into the clinical workflow in
the hospital to improve the quality and efficiency of maintaining glucose
Improved glucose management in critical care patients may reduce morbidity,
mortality and the length of stay.(1-3) While glucose control is a standard
practice for diabetic and non-diabetic patients in the CCU, it's difficult to
achieve. The Sentrino CGM System and the trending data it provides help
optimize glucose management practices. Sentrino is an investigational device
only in the US and not approved for sale in the US.
"Introduction of the CGM technology in critically ill patients is a high
priority that will help improve our insight in insulin resistance, will increase
understanding of the effects of glycemic variability and will facilitate any
blood glucose control strategy. Using the Sentrino CGM System for my intensive
care patients will alert me to impending hypo or hyperglycemia, and will be
invaluable in better maintaining glucose control," said Prof. M.J. Schultz, MD,
PhD, in the Intensive Care Medicine Department at Academisch Medisch Centrum
(AMC) in Amsterdam.
Sentrino continuously displays the patient's interstitial glucose value in real
time on its monitor, and it provides predictive alarms and alerts if the
patient's glucose values fall outside the target range selected by the physician
so clinicians can react proactively. It enables clinicians to transition to an
event-based protocol from a time-based measurement protocol, which is the
current standard of care with blood glucose measurements taken every two-to-four
The Sentrino CGM System was designed to address the unique needs of critical
care patients with a highly innovative design and unique ability to integrate
into clinical protocols including:
* Redundant sensing technology that optimizes signal reliability for more
accurate visibility of glycemic variability.
* A minimally invasive, subcutaneous sensor customized for the critical care
patient and inserts quickly and easily with low complication rates.
* A novel drug interference rejection technology that ensures minimal
interference with the wide array of pharmaceuticals used in the critical
* An easily configurable system that integrates simply into clinical workflow.
"Despite its many benefits, good glycemic control is difficult to achieve in the
CCU, and that's why we developed Sentrino. Medtronic has a decade of CGM
expertise, and we coupled it with extensive clinical research to develop the
Sentrino CGM System for critically ill patients," said Greg Meehan, vice
president and general manager of the Continuous Glucose Monitoring business at
Medtronic. "Given the market need for CGM in CCU patients, we believe the market
potential will exceed $1 billion globally."
About Hospital-based Continuous Glucose Monitoring (CGM)
Glucose control is a standard practice in critical care units whether or not
patients have diabetes because it improves outcomes. Over the past 10 years,
CGM has been evaluated in monitoring glucose trends in critically ill patients,
yielding positive results(4-8 ) with investigators achieving significantly lower
rates of hypoglycemic events (BG < 2.2 mmol/L, 40 mg/dL).(8 )CGM provides a more
complete picture because it reveals high and low glucose levels that periodic
blood glucose testing might miss. This trending data allows clinicians to
appropriately intervene to prevent glycemic excursions and maximize the
patient's time in the target range. The information provided by CGM is intended
to supplement, not replace, readings obtained from approved blood glucose
measuring devices and should be confirmed prior to making therapy adjustments.
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
(1) Krinsley JS, Schultz MJ, Spronk PE, et al. Mild hypoglycemia is
independently associated with increased mortality in the critically ill. Crit
(2)Krinsley JS, Schulz MJ, Spronk PE, et al. Mild hypoglycemia is strongly
associated with increased intensive care unit length of stay. Ann Intensive
(3)Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in
critically ill patients. N Engl J Med. 2001;345(19):1359-1367.
(4)Brunner R, Kitzberger R, Miehsler W, et al., Accuracy and reliability of a
subcutaneous continuous glucose-monitoring system in critically ill patients.
Crit Care Med. 2011; 39:1-6.
(5) Holzinger U, Warszawska J, Kitzberger R, et al., Impact of shock requiring
norepinephrine on the accuracy and reliability of subcutaneous continuous
glucose monitoring. Intensive Care Med. 2009; 35:1383-1389.
(6) Monsod TP, Glanagan DE, Rife F, et al., Do sensor glucose levels accurately
predict plasma glucose concentrations during hypoglycemia and hyperinsulinemia?
Diabetes Care. 2002; 25:889-893.
(7) Corstjens AM, Ligtenberg JJM, Van der Horst ICC, et al., Accuracy and
feasibility of point-of-care and continuous blood glucose analyses in critically
ill ICU patients. Crit Care. 2006;10(5):R135. Available at
(8) Holzinger U, Warszawska J, Kitzberger R, et al., Real-time continuous
glucose monitoring in critically ill patients. Diabetes Care. 2010; 33:467-472.
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