Medtronic files PMA for MiniMed 530G System for Diabetes monitoring and treatment - 09-Jun-2012

Medtronic has filed the final module of its Pre-Market Approval (PMA) application with the FDA for the MiniMed 530G system, an integrated insulin pump and continuous glucose monitor 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 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. In addition, this PMA submission includes data from the pivotal trial of the Enlite sensor, Medtronic's newest and most advanced continuous glucose sensor. The Enlite sensor is smaller for greater comfort and has been designed to offer improved accuracy and greater hypo detection capabilities, compared to Medtronic’s Sof-Sensor.