Medtronic Begins Initial European Market Launch of World's First Combined Glucose Sensor and Insulin

http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1936694&highlight=
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[TD="class: first-col"]Medtronic Begins Initial European Market Launch of World's First Combined Glucose Sensor and Insulin Infusion Set for People with Diabetes[/TD]
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MiniMed® Duo(TM) Enhances Simplicity and Comfort of Sensor Augmented Insulin Pump Therapy​

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TOLOCHENAZ, SWITZERLAND - June 3, 2014 - Medtronic, Inc. (NYSE:MDT) today announced the European launch of MiniMed® Duo(TM), the world's first two-in-one breakthrough that combines a glucose sensor and insulin infusion set into one on-body device, simplifying integrated insulin pump therapy and continuous glucose monitoring (CGM). MiniMed Duo, which is used with the MiniMed® Veo(TM) system, makes it easier for more people with diabetes to benefit from CGM. The product received CE (Conformité Européenne) mark this week.
Insulin pumps provide precise insulin delivery and lifestyle flexibility for people with diabetes by delivering small amounts of insulin around-the-clock. Insulin pumps integrated with CGM are clinically proven to provide better glucose control than multiple daily injections[1] or pump therapy alone[2]. Better glucose control reduces the risk of diabetes complications such as eye disease, kidney disease and nerve damage.[3] Insulin pumps with built-in CGM provide people with diabetes with real-time glucose values and customizable alerts that give warning before glucose levels go too high or too low, prompting the person with diabetes to take action. The MiniMed® Veo(TM) is the only integrated system with an automatic insulin shut-off mechanism if glucose levels fall too low, providing protection against hypoglycemia (low blood glucose). Traditional finger stick tests alone often miss up to 78% of potentially dangerous highs and lows[4], resulting in a higher risk for diabetes complications.
"CGM provides people with diabetes with real-time information about their glucose levels that is invaluable in helping them optimize their diabetes management. However, in the past, many people have been reluctant to use a system that requires them to wear two separate devices on their bodies. By integrating a glucose sensor and infusion set into one device, MiniMed Duo will make it easier and more comfortable for these patients to adopt and experience the benefits of CGM technology," said Dr. Francine Kaufman, Chief Medical Officer and Vice President of Global Clinical Affairs for Medtronic Diabetes.
Benefits of the MiniMed Duo include:

• Enhanced simplicity:
  
  • Both the glucose sensor and cannula (the tiny tube that goes into the body to deliver the insulin) are inserted with one easy-to-use insertion device.
    
  • People with diabetes only have to remember to change one device every 3-days.
    
  • There's no need to manage two different sites on the body while bathing, exercising or being active.
    
• Greater comfort:
  
  • A smaller footprint on the body (compared to a separate CGM sensor and infusion set) means less skin covered by adhesive tape.
    
  • A single-button insertion and automatic needle retraction (so patients don't have to see the needle) were specifically designed for greater comfort.
    
  • In a study, 95.8% of people using MiniMed Duo rated pain at the time of insertion at 0 or 1 out of 10[5].
    
  • An improved adhesive pad accommodates movement without compromising adhesion.

"For over 30 years, Medtronic has been dedicated to developing world-class technologies to provide better outcomes and simplify diabetes management," said Greg Meehan, Vice President and General Manager of the Continuous Glucose Monitoring business at Medtronic Diabetes. "MiniMed Duo is the latest breakthrough designed in response to the needs of insulin pumpers who don't want to wear two separate devices on their bodies, addressing one of the most common barriers to CGM technology."
The MiniMed Duo received CE (Conformité Européenne) Mark approval and, as the first stage of a progressive rollout across Europe, will be available in select countries in the next few months, pending local approvals. The device is not available in the United States.

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.
About Medtronic
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.

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[HR][/HR][1] Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med.2010;363:311-320.

[2] Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial. Diabetologia. 2012;55:3155-3162.

[3] The Diabetes Control and Complication Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. J Pediatr 1994; 125: 177-88

[4] Kaufman FR, Gibson LC, Halvorson M, Carpenter S, Fisher LK, Pitukcheewanont P. A pilot study of continuous glucose monitoring system. Diabetes Care. 2001;24:2030-2034.

[5] Data on File.



Contacts:
Amanda Sheldon
Public Relations
+1-818-576-4826

Jeff Warren
Investor Relations
+1-763-505-2696

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Have pretty mixed feelings about this. Looking at this pic;
so this has two "holes".

So how is this a progress/breakthrough (taken into account that it needs to changed every 2-3 days)?