FDA to Review World’s First Insulin Pump with Threshold Suspend – Another Significant Step Toward the Artificial Pancreas
FDA to Review World’s First Insulin Pump with Threshold Suspend – Another
Significant Step Toward the Artificial Pancreas
MINNEAPOLIS – June 8, 2012 –In the next step toward the development of an artificial pancreas, Medtronic, Inc. (NYSE:MDT) today announced that it has filed the final module of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration for the MiniMed® 530G system featuring Threshold Suspend Automation. If approved by the FDA, the MiniMed® 530G system will be the only integrated insulin pump and continuous glucose monitor in the United States that automatically suspends insulin delivery if the sensor glucose value is equal to or below the low threshold value.
Medtronic’s PMA submission includes data from the in-clinic ASPIRE (Automation toSimulate Pancreatic Insulin REsponse) study, which met its efficacy endpoints and showed a reduction in time spent below the low glucose threshold in people with diabetes using the Threshold Suspend Automation feature, compared to conventional pump therapy. The in-home ASPIRE study is still ongoing.