FDA Approves Medtronic’s Artificial Pancreas

The FDA has approved a new, automated artificial pancreas system from Minneapolis-based Medtronic, Inc.

The innovative, first-generation system is the first of its kind in the United States, and has the capability to automatically stop insulin delivery when blood glucose levels are either too high or too low.

The MiniMed 530G with Enlite sensor is one of many innovations in diabetic treatment options from Medtronic. The company developed the world’s first insulin pump in 1983 and followed with an integrated insulin pump and glucose monitoring system in 2006.

In addition to an insulin pump and a continuous glucose monitor fitted with the improved Enlite sensor, the MiniMed 530G artificial pancreas includes the Threshold Suspend system, which has the capability to automatically stop insulin delivery in response to preset glucose levels determined by a healthcare provider.

Working in conjunction with the pump and monitor, the Threshold Suspend system uses advanced technology to automatically cease delivery of insulin if glucose levels reach a preset threshold and if the user is unable to respond to the Threshold Suspend alarm. If the user is sleeping, the system will suspend insulin delivery for up to two hours, reducing the risk of hypoglycemia or hyperglycemia.

For those with type 1 diabetes, where the pancreas no longer produces insulin, an artificial pancreas is designed to mimic the insulin delivery of a healthy pancreas by providing both continuous glucose monitoring and automatically adjusted insulin delivery that intervenes when glucose is severely low or severely high.

The MiniMed 530G system is approved for use by those with diabetes 16 and older, though Medtronic plans to conduct a post-approval study that will include children 2 and up.

For more information, visit www.medtronicdiabetes.com.