ALERT: Due to the inclement weather across much of the country, Medtronic deliveries are currently experiencing delays and there will be longer than normal hold times on the phone. Visit www.Diabetes.Shop if you need to place an order, get a sensor or belt clip replacement, or check the status of your supply order. X

Innovation Milestones

Innovating Since 1983


2021
2021

International Launch of Extended Wear Infusion Set

In Europe, Medtronic introduced the first and only infusion set that can be worn for up to 7 days. The Medtronic Extended infusion set doubles the length of time an infusion set can be worn.

2020
2020

Integrated Smart Insulin Pen with Real-time CGM

Medtronic integrated InPen™ with real-time Guardian™ Connect continuous glucose monitoring (CGM) data. This integrated system provides real-time glucose readings alongside insulin dose information giving customers everything they need to manage their diabetes in one view. Rather than switching between apps, they have the ability to see all their information in real-time, in one view — making it easier to make smarter dosing decisions to manage their sugar levels.

2020
2020

U.S. Launch of the MiniMed™ 770G System

MiniMed™ 770G hybrid closed loop system offers the company’s advanced SmartGuard™ technology, as featured in the MiniMed™ 670G system, with the added benefits of smartphone connectivity and an expanded age indication down to the age of 2 years old.

2020
2020

Acquisition of Companion Medical

Medtronic acquired Companion Medical, manufacturer of InPen™ — the only U.S. FDA-cleared smart insulin pen system paired with an integrated diabetes management app on the market. The addition of Companion Medical’s InPen to the Medtronic portfolio expands the company’s ability to serve people where they are in their diabetes journey and offer them a unique and expansive ecosystem of support — regardless of how insulin is delivered.

2020
2020

International Launch of MiniMed™ 780G System

Medtronic introduced MiniMed™ 780G system, a next generation closed loop insulin pump system for the treatment of type 1 diabetes. Leveraging the company’s most advanced SmartGuard™ algorithm, the system automates the delivery of both basal insulin and correction boluses every five minutes. The MiniMed 780G system also enables the personalization of glucose goals with an adjustable target setting as low as 100 mg/dL (5.5 mmol/L).

2019

Acquisition of Klue

Medtronic acquired Klue, a software company focused on behavior tracking that can provide real-time insights into when a person is consuming food. Klue has developed technology that automatically recognizes when a person is eating as well as how fast and how much that person consumes. By using gesture sensing via activity trackers combined with analytics technology, Klue has developed fine motor artificial intelligence software that can detect meals and provide insights into user eating behaviors.

2018

Medtronic Acquires Nutrino Health

Medtronic acquired Nutrino Health, a leading provider of nutrition-related data services, analytics, and technologies. Because food and nutrition are central components in effective diabetes management, this acquisition created an opportunity to improve clinical outcomes for people with diabetes by integrating Nutrino's extensive food analysis infrastructure, nutrition science expertise and artificial intelligence (AI)-driven personalized insights with future technology and innovations.

2018
2018

U.S. Launch of the Guardian™ Connect CGM System for People Living with 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. 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 smart diabetes assistant, empowering them to further address the daily challenges of diabetes. with the Guardian Connect system, the Sugar.IQ assistant can turn difficult-to-determine patterns into personalized insights that help people with diabetes keep glucose levels in their target range.

2016
2017

Medtronic Launches MiniMed™ 670G, the World's First Hybrid Closed Loop System for Type 1 Diabetes

U.S. launch of the MiniMed™ 670G system - the world's first Hybrid Closed Loop system for people with type 1 diabetes. Featuring the company's most advanced SmartGuard technology and Guardian Sensor 3, it is the only insulin pump approved by the Food and Drug Administration (FDA) that enables personalized and automated* delivery of basal insulin, the background insulin needed to maintain stable blood sugar levels throughout the day and night. The advanced SmartGuard Auto Mode algorithm works in conjunction with the company's most accurate sensor to date - Guardian Sensor 3 - to self-adjust basal insulin delivery every five minutes based on real-time needs. Through this personalized design, the system is able to help maximize Time in Range - the amount of time sugar levels stay within a range considered healthy by clinical standards. The system also exclusively features the CONTOUR®NEXT LINK 2.4 blood glucose monitoring system (BGMS) from Ascensia Diabetes Care.

2016
2016

U.S. Launch of the MiniMed™ 630G System with New User-Friendly Insulin Pump Design and SmartGuard Technology

U.S. commercial launch of the MiniMed™ 630G system with SmartGuard technology, FDA approved for the treatment of people with diabetes mellitus fourteen years of age and older with Guardian Sensor 3, sixteen years of age and older with Enlite sensor. The MiniMed™ 630G features a new insulin pump hardware platform and new user-friendly design that combines personalized diabetes management with industry-leading clinical performance.

2015
2015

International Launch of MiniMed™ 640G

Medtronic launches the MiniMed™ 640G system, a breakthrough toward an artificial pancreas for people with diabetes, outside the United States (U.S.). The new system incorporates a new insulin pump design to provide convenient diabetes management with a simple user interface, full-color screen, remote bolus, and is waterproof in up to 3.6 meters of water for up to 24 hours at a time.
*Not FDA approved or commercially available for sale in the U.S.

2014

Launch of MiniMed™ 620G in Japan

Medtronic receives regulatory approval of the MiniMed™ 620G system in Japan, the country’s first insulin pump with built-in continuous glucose monitoring (CGM) designed to deliver better clinical outcomes for people with diabetes. The system also is the first insulin pump with Japanese-language menus and incorporates a simple user interface, full-color screen, remote bolus, and is waterproof in up to 3.6 meters of water for up to 24 hours at a time.
*Not FDA approved or commercially available for sale in the U.S.

2014

Enrollment Begins in Pivotal Study of First Predictive Low Glucose Management Technology

The first patients have been enrolled in an investigational device exemption (IDE) study of Medtronic’s Predictive Low Glucose Management (PLGM) technology. The trial will evaluate the safety of its next-generation integrated insulin pump and CGM system, which automatically stops insulin delivery when the sensor measures sensor glucose level predicted to approach the low limit, and then resumes insulin delivery once sensor glucose levels recover.

2014

Results of OpT2mize Trial Published in The Lancet

The Lancet publishes results of the OpT2mise trial, which shows that MiniMed™ insulin pumps safely achieve better glucose control for people with insulin-requiring type 2 diabetes than multiple daily injections.3 The largest, global study of its kind, OpT2mise provides strong clinical evidence for expanding access to insulin pump therapy for people with type 2 diabetes with poor glycemic control.

2014
2014

Distribution of i-Port™ Advance Injection Port Device

Medtronic gains distribution rights for i-Port™ Advance, a three-day-wear device that people on insulin injection therapy use to inject insulin into a port instead of injecting directly into the skin. The product eliminates the need to puncture the skin with each insulin injection and allows Medtronic to meet the needs of a broader group of people with diabetes.

2013
2013

FDA Approval of MiniMed™ 530G with Enlite™, First FDA-Approved Artificial Pancreas Device System with Threshold Suspend Automation

FDA approves MiniMed™ 530G with Enlite, a breakthrough, first-generation artificial pancreas device system with Threshold Suspend automation for people with diabetes 16 years of age or older. The 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.

2013

ASPIRE Study on Medtronic Insulin Pump with Low Glucose Suspend Published

ASPIRE In-Home study results published in the New England Journal of Medicine and presented at the American Diabetes Association (ADA) 73rd Scientific Sessions.

2012

JDRF Partners with Medtronic to Advance CGM Towards Artificial Pancreas Systems

Medtronic partners with the JDRF, in collaboration with the Helmsley Charitable Trust (HCT), to advance CGM accuracy and reliability towards the next generation artificial pancreas systems. The partnership focuses on accelerating the development of Medtronic’s redundant sensor system to deliver more accurate CGM technology for people with diabetes.

2012
2012

Introduction of mySentry, the First Remote Glucose Monitor

FDA approves the first-of-its-kind mySentry Remote Glucose Monitor, which allows a parent or caregiver to monitor a patient’s MiniMed™ Paradigm™ REAL-Time Revel system from another room. The remote glucose monitor also marks the launch of a new category of Connected Care solutions that will provide people with diabetes and their caregivers convenient options to access their diabetes management information.

2011
2011

FDA Approval of iPro™2 CGM

Medtronic gains FDA approval of and launches iPro2, a next generation professional CGM system that simplifies professional CGM and enables healthcare providers to obtain a more complete picture of glucose control for the patients they treat.

2011

International Launch of Enlite Sensor

The Enlite sensor receives CE approval and is launched in more than 35 countries outside of the U.S., providing international users with a more accurate and comfortable sensor. Enlite marks significant clinical and human factor improvements for CGM, combing greater comfort with improved glucose sensor performance in both overall accuracy and detection of hypoglycemia (low blood glucose).1,2
*FDA approved and commercially available in the U.S. since September 2013.

2010

Medtronic Launches CareLink® Pro 3.0, the First Diabetes Management Software to Offer Advanced Decision Support

CareLink Pro 3.0 Therapy Management Software, the first software program to offer advanced decision support to healthcare professionals managing diabetes, is launched in the United States. The software offers therapy considerations that clinicians can use as a starting point to discuss therapy changes with their patients to help improve glucose control.

2010

STAR 3 Trial Results Confirm Medtronic’s Sensor-Augmented Insulin Pump Therapy Achieves Better Glucose Control than Daily Insulin Injections in People with Diabetes9

STAR 3 study results published in the New England Journal of Medicine and presented at the American Diabetes Association (ADA) 70th Scientific Sessions report adults and children using the Medtronic MiniMed™ Paradigm REAL-Time System achieved better glucose control without an increase in hypoglycemia (low blood glucose), compared to multiple daily insulin injections (MDI). STAR 3 is the longest and largest randomized, controlled study of sensor-augmented insulin pump therapy in type 1 diabetes.

2010
2010

FDA approval of the MiniMed™ Paradigm REAL-Time Revel™ System

FDA approval of the MiniMed™ Paradigm REAL-Time Revel system, the second generation of Medtronic’s industry-leading integrated diabetes management system that combines insulin pump therapy, CGM and diabetes therapy management software. The system incorporates new innovative CGM features such as predictive alerts, which can give early warning to people with diabetes to dangerous high or low glucose events up to thirty minutes before they occur so they can take action sooner.

2009

New Diabetes Center in San Antonio Opened

Medtronic opens new customer care and education center in San Antonio, TX for customers and healthcare professionals using Medtronic insulin pumps, CGM and therapy management software for the treatment of diabetes.

2009
2009

International Launch of MiniMed™ Veo™, the World's First Step to an Artificial Pancreas

Medtronic receives CE Mark approval of the MiniMed™ Veo™ System in more than 50 countries outside of the United States. The new system is the world’s first with Low Glucose Suspend, a feature that automatically stops insulin delivery when sensor glucose levels hit a preset low threshold.
*Not FDA approved or commercially available for sale in the U.S.

2008

FDA Approval of iPro™ CGM

FDA approves iPro, a professional CGM system for professional use. This “blinded” CGM system allows healthcare professionals to uncover glucose patterns and trends that often go undetected with fingerstick and A1C testing alone.

2007
2007

Launch of Guardian™ REAL-Time System with MiniLink Transmitter and CareLink™ Personal Software

Medtronic launches the Guardian REAL-Time system, a stand-alone personal CGM system that provides sensor glucose readings throughout the day as well as alerts to dangerous highs and lows. The new CGM system includes a smaller transmitter that is waterproof up to a depth of 8 feet for up to 30 minutes when connected to the glucose sensor10, and incorporates CareLink Personal Therapy Management Software.

2007

FDA Approves New Medtronic CGM Devices for Children and Teenagers

FDA approves new REAL-Time CGM devices for children and teenagers ages 7 – 17, which was previously only indicated for adults.

2006
2006

FDA Approval of World’s First Integrated Diabetes Management System, the MiniMed™ Paradigm™ REAL-Time System

FDA approval of the MiniMed™ Paradigm™ REAL-Time system Insulin Pump and CGM system, the first diabetes management integrated system and a major step toward the development of a "closed-loop" insulin delivery system or artificial pancreas that may one day mimic some functions of the human pancreas. The system was indicated for adult patients.

2005

Completion of the GuardControl Trial Using the Guardian REAL-Time CGM System

The GuardControl Trial results published in Diabetes Care report adults and children using Medtronic Guardian REAL-Time CGM achieved better glucose control, compared to fingersticks alone.11 GuardControl is the first international, large-scale, multi-center, randomized clinical outcome trial conducted to evaluate the use of Medtronic’s CGM technology for improved diabetes management for people with type 1 diabetes.

2005
2005

FDA Approval of Guardian RT CGM System

FDA approves Guardian RT CGM system. This patient-use CGM system displays updated real-time glucose values every five minutes and sounds an alarm when sensor glucose levels become too high or too low, helping people with diabetes who desire better glucose control.

2004

Introduction of CareLink Therapy Management Software

Medtronic Diabetes introduces CareLink Therapy Management system for Diabetes, providing people with diabetes with free, secure Web-based software that allows them to identify trends from information downloaded from their insulin pumps.

2004

FDA Approval of Patient-Use Guardian CGM System

The FDA approves the Guardian CGM system, a medical device designed to notify diabetes patients from potentially dangerous high and low glucose fluctuations by sounding an alarm.

2003

FDA Approval of First Wireless Insulin Pump System

Medtronic Diabetes introduces the world's first "intelligent" insulin pump, which wirelessly and automatically transmits a glucose value from the blood glucose meter to the insulin pump, where the Bolus Wizard™ calculator recommends proper insulin dosages. The system utilizes a MiniMed™ Paradigm™ 512 Insulin Pump and a Paradigm Link® Blood Glucose Monitor, co-developed with BD (Becton, Dickinson and Company).

2003

CGMS® System Gold® Presented at the American Diabetes Association (ADA)

CGMS system Gold is presented at the American Diabetes Association (ADA) conference. The new system is used by physicians and includes an enhanced glucose sensor, easier to use monitor, and easier to understand graphs and charts to track their patient’s continuous sensor glucose patterns.

2001

Medtronic Acquires MiniMed

MiniMed, Inc. and Medical Research Group (MRG) are combined to create Medtronic MiniMed, Inc., which is headquartered in Northridge, California. As Medtronic's diabetes business unit, the company continues its pioneering leadership in diabetes management with specialties in insulin delivery, CGM, advanced algorithm development and therapy management software.

2001
2001

Introduction of the Quick-set™ Infusion Set

The Quick-set infusion set is unveiled, offering customers the most favorable features of existing infusion sets into one product. A low profile disconnect at the infusion site, 90-degree soft cannula, along with a virtually painless insertion at the touch of a button quickly make it our most popular infusion set.

2000

CE Mark Approval for the Next Generation Implantable Insulin Pump

CE mark approval is received for the implantable insulin pump Model 2007-A, enabling the device to be commercially distributed in Europe. This insulin pump is intended for a small subset of people with type 1 diabetes who cannot achieve glucose control through subcutaneous insulin delivery, and delivers insulin through the peritoneal cavity. In March 2003, the U-400 insulin (semi-synthetic insulin) made by Aventis and used with the implantable insulin pump is approved by AFSSAPS, the French regulatory authority.
*Not FDA approved or commercially available for sale in the U.S.

1999
1999

Introduction of the MiniMed™ 508 Insulin Pump

The MiniMed™ 508 insulin pump is introduced, offering new features such as remote programming capabilities to administer or suspend insulin delivery, the ability to program multiple patient-specific delivery patterns, a low volume alert, optional vibrate mode, and child-block.

1999

FDA Approval of the First Physician-Use Glucose Monitoring System

FDA approves the first-ever physician-use CGM system This historical device records glucose values over a 3-day period, after which trend data is downloaded in a healthcare professional's office for analysis. The system is used for establishing a baseline glucose profile, initiating and monitoring therapy, and determining appropriate intervention if a patient is encountering problems with their glucose control.

1996

Start of Clinical Trials for Glucose Sensor

A critical component in ultimately creating a "closed-loop" insulin delivery system, MiniMed™ glucose sensor moves from the laboratory to actual human clinical trials.

1994

Introduction of Quick Release™

Quick Release is introduced, providing customers with a new level of freedom and flexibility by allowing them to temporarily detach from the insulin pump at the infusion site without having to insert a new infusion set.

1992

Launch of the MiniMed™ 506 Insulin Pump

The MiniMed™ 506 insulin pump is introduced. A major redesign in its programming, electronics and mechanics, the MiniMed™ 506 delivers advanced features such as meal bolus memory and daily insulin totals.

1987
1987

Introduction of the Sof-set™ Infusion Set

The Sof-set infusion set is introduced. The first infusion set to replace the metal needle with a soft flexible cannula, Sof-set represents the maturation of insulin pump therapy and the company's ability to prioritize customer comfort.

1983
1983

Commercialization of the First MiniMed Insulin Pump

MiniMed introduces their first insulin pump, the MiniMed™ 502. The 502A soon follows, representing a major technological breakthrough in both size and programmability over the previous model.

1979
1979

Al Mann Becomes Interested in Creating an Insulin Pump

Alfred E. Mann, then the CEO of Pacesetter systems, becomes interested in creating an insulin pump after a conversation with a cardiologist at the University of Alabama, who tells Mann about the severity of heart problems due to diabetes.

1949

Development of the First Battery Operated Pacemaker

After evolving from simply repairing medical equipment to improving it, Medtronic is approached by Dr. Lillehei at the University of Minnesota Medical School about his need for better pacemakers. Earl Bakken and his team create the first wearable, battery-operated pace maker, a leap forward for cardiac care and the launch of Medtronic's journey to become the world's leading medical device company.

1949

The Founding of Medtronic

Earl Bakken and his brother-in-law, Palmer Hermundslie, begin a medical equipment repair shop in Earl's garage.



* Refers to SmartGuard Auto Mode. Some user interaction required. Individual results may vary.

** The MiniMed 770G system is enabled for future software upgrades, when such software upgrades are available.

† At the time of manufacture and when the reservoir and tubing are properly inserted, your pump is waterproof. It is protected against the effects of being underwater to a depth of up to 12 feet (3.6 meters) for up to 24 hours.

∆ The Threshold Suspend feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend feature, it is important to read the Threshold Suspend information in the MiniMed 530G System User Guide and discuss proper use of the Threshold Suspend feature with your healthcare provider.

‡ Not FDA cleared or commercially available for sale in the U.S.

◊ Smart insulin pens connect to a mobile app to provide dosing calculations, reminders and CGM system integration.

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.

2 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 UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complication in patients with type 2 diabetes (UKPDS 33). Lancet. 1998; 352:837-853.


Important Safety Information: MiniMed 770G System With SmartGuard Technology

The MiniMed 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 770G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring (CGM) sensor glucose values (SG) and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed 770G System consists of the following devices: MiniMed 770G Insulin Pump, the Guardian Link (3) Transmitter, the Guardian Sensor (3), one-press serter, the Accu-Chek® Guide Link blood glucose meter, and the AccuChek®Guide Test Strips. The system requires a prescription.

The Guardian Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian Sensor (3).

All therapy adjustments should be based on measurements obtained using the Accu-Chek® Guide Link blood glucose meter and not on values provided by the Guardian Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the Accu-Chek® Guide Link blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.

WARNING: Do not use the SmartGuard Auto Mode for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in SmartGuard Auto Mode.

WARNING: Do not use the MiniMed 770G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed 770G system.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed 770G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.medtronicdiabetes.com/important-safetyinformation#minimed-770g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library


Important Safety Information: Guardian Connect CGM System


The Guardian Connect system requires a prescription and is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices, and is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day, or for people who are unable or unwilling to maintain contact with their healthcare professional. The system requires a functioning mobile electronic device with correct settings. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide at http://www.medtronicdiabetes.com/support/download-library/user-guides and important safety information.


Important Safety Information: MiniMed 670G System


The Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, seven years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G system includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The system requires a prescription. The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOUR®NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an Alternative Site (palm) or from a control solution test. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode.


WARNING: Medtronic performed an evaluation of the MiniMed 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed™ 670G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-670g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library


Important Safety Information: MiniMed 630G System with SmartGuard Technology


Indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 630G system is approved for ages 16 years or older with Enlite™ sensor. Both systems require a prescription. Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy. Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Replace the infusion set every 48–72 hours, or more frequently per your healthcare professional’s instructions. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter. A confirmatory fingerstick using a CONTOUR®NEXT LINK 2.4 meter is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK 2.4 meter, to ensure the glucose result shown agrees with the glucose results shown on the meter. Do not calibrate your CGM device or calculate a bolus using a result taken from an Alternative Site (palm) or a result from a control solution test. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. The MiniMed™ 630G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

WARNING: The SmartGuard™ Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again, resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the SmartGuard™ feature, it is important to read the SmartGuard™ feature information in the User Guide and discuss proper use of the feature with your healthcare provider.

See www.medtronicdiabetes.com/importantsafetyinformation and the appropriate user guides for additional important details.

Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. Please visit www.medtronicdiabetes.com/importantsafetyinformation for more details.

The CONTOUR®NEXT LINK 2.4 Meter is used with the MiniMed 630G system.


Important Safety Information: MiniMed 530G System with SmartGuard Technology

The MiniMed™ 530G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 530G system can be programmed to automatically suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value.

The MiniMed™ 530G system consists of the following devices that can be used in combination or individually: MiniMed™ 530G insulin pump, Enlite™ sensor, Enlite™ serter, the MiniLink™ Real-Time transmitter, CONTOUR®NEXT LINK wireless meter, CareLink™ Pro therapy management software for diabetes, and CareLink™ Personal therapy management software for diabetes. The system requires a prescription.

The MiniMed™ 530G system is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed™ 530G system. The MiniMed™ 530G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm to take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

WARNING: The "SmartGuard™ feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend feature, it is important to read the Threshold Suspend information in the Getting Started Guide and the MiniMed™ 530G System User Guide and discuss proper use of the Threshold Suspend feature with your healthcare provider.

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day.

Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

See Instructions for Use (IFU) for additional details.

http://www.medtronicdiabetes.com/download-library/minimed-530g


Important Safety Information: iPro2 Professional Continuous Glucose Monitoring (CGM)

The iPro2™ digital recorder is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. The information collected by the iPro2™ digital recorder may be uploaded to a computer (with Internet access) and reviewed by healthcare professionals. The information may allow identification of patterns of glucose-level excursions above and below a desired range, facilitating therapy adjustments, which may minimize these excursions.

  • The iPro2™ system is intended for prescription use only.
  • Does not allow data to me made available directly to patients in real time
  • Provides data that will be available for review by physicians after the recording interval (up to72 hours for Sof-sensor glucose sensor; 144 hours for Enlite™ sensor)
  • Is intended for occasional rather than everyday use
  • Is to be only used as a supplement to, not a replacement for, standard invasive measurement

See Instructions for Use (IFU) for additional details.

http://www.medtronicdiabetes.com/download-library/ipro-2


Important Safety Information: i-Port Advance injection port

i-Port Advance™ injection port is indicated for patients who administer or receive multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple injections without the discomfort of additional needle sticks. i-Port Advance™ injection port may be used on a wide range of patients, including adults and children. For more, please see http://www.medtronicdiabetes.com/important-safety-information.


Important Safety Information: Infusion Sets

Infusion sets are indicated for the subcutaneous infusion of insulin from an infusion pump. Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products. Inaccurate medication medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site. Before insertion, clean the insertion site with isopropyl alcohol. Remove the needle guard before inserting the infusion set. If
using this infusion set for the first time, do the first set-up in the presence of your healthcare professional. Do not leave air
in the infusion set. Prime completely. Check frequently to make sure the soft cannula remains firmly in place as you
may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication. If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin. Replace the infusion set every 48-72 hours, or per your healthcare professional’s instructions. NOTE: Product use duration varies from 48-72 hours fro most infusion set types - and 168 hours for the Extended Wear Set. Please consult the applicable user guide for details.