Medtronic Completes Global User Evaluations for New Insulin Pump Platform

From Medtronic:

Medtronic Completes Global User Evaluations for New Insulin Pump Platform

Next-Generation System with Breakthrough Advancement in Closed-Loop Technology Furthers Global Innovation MINNEAPOLIS - December 19, 2014 - Medtronic, Inc. (NYSE:MDT) today announced it has completed global user evaluations of a next generation system that uses the new pump platform and represents a key step toward development of an artificial pancreas. The completely redesigned insulin delivery system comes with new features that offer convenience in managing diabetes and improved design elements that make the system easy to use. Medtronic's next generation system uses the new platform along with a new Predictive Low Glucose Management (PLGM) algorithm. PLGM automatically stops insulin delivery when the sensor measures a glucose level predicted to approach the predetermined lowest  limit, and then resumes insulin delivery after those glucose levels recover.  Manufacturing has been initiated, and product introduction in select countries is set for early calendar year 2015. A pivotal trial is currently underway in the United States to evaluate PLGM technology as well. "By delivering on our commitments to drive technical innovations around the world, we aim to transform diabetes care so that more people living with diabetes can enjoy greater freedom and experience better health," said Alejandro Galindo, vice president and general manager of the Intensive Insulin Management business at Medtronic. Continued advancements in technologies to manage diabetes are driving better health outcomes. The landmark STAR 3 study concluded that adults, children and adolescents can achieve better glucose control without an increase in hypoglycemia by using integrated insulin pump therapy with CGM compared to the current standard of care - multiple daily injectionsi. Improving glycemic control reduces the risk of long-term diabetes complications such as eye disease, kidney disease, nerve damage and heart disease. The introduction of a new insulin delivery platform that offers more convenience in managing diabetes demonstrates the next step toward Medtronic's ultimate goal of developing a fully automated artificial pancreas - a system that would automatically adjust insulin levels based on sensor glucose levels with very little interaction from the patient. Previous milestones include: 2006: Medtronic introduced the world's first integrated insulin pump and continuous glucose monitor 2009: Medtronic introduced the world's first integrated insulin pump with Low Glucose Suspend technology in Europe 2013: Medtronic introduced the MiniMed 530G with Enlite, which features Threshold Suspend technology, in the U.S. 2014: Medtronic begins pivotal trial for PLGM technology in the U.S. About the Diabetes Group at Medtronic(www.medtronicdiabetes.com) Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health. 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. - end - i According to the STAR 3 clinical study: 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.