Today, we received word that Medtronic received FDA approval for the for the MiniMed530G with Enlite. Here’s the announcement:
“I am excited to share the great news that Medtronic just received FDA approval for the MiniMed 530G with Enlite. As you know, this is Medtronic’s third generation integrated system and the first to be approved under a new device classification: OZO: Artificial Pancreas Device System, Threshold Suspend…..
Today, we received word that Medtronic received FDA approval for the for the MiniMed530G with Enlite. Here's the announcement:
"I am excited to share the great news that Medtronic just received FDA approval for the MiniMed 530G with Enlite. As you know, this is Medtronic’s third generation integrated system and the first to be approved under a new device classification: OZO: Artificial Pancreas Device System, Threshold Suspend. In fact, the FDA created this new designation to mark a significant new era in which insulin delivery is automatically responding to a patient’s glucose sensor values.
Threshold Suspend technology, which automatically stops insulin delivery when the sensor glucose level reaches a pre-set low threshold, is available only with the MiniMed 530G system. The Threshold Suspend feature is designed for situations when patients do not respond to low glucose sensor alarms and no one is available to help them. Threshold Suspend is similar to Low Glucose Suspend, or LGS, which is available internationally as part of the “Veo system. As reported in the ASPIRE clinical study and other publications, Threshold Automation mimics some of the functionality of a healthy pancreas.
The Enlite sensor, approved for use only with our MiniMed 530G system, is our newest and most advanced glucose sensor for continuous glucose monitoring (CGM). Not only is Enlite 69% smaller, but accuracy and comfort are all significantly better than the current Sof-sensor. The hypo detection rate has improved to 93% when predictive and low alerts are also used. Even the insertion process has been redesigned so that it is easier. The guide needle automatically retracts and is hidden from view the entire time.
This approval truly demonstrates the importance of Medtronic’s partnership with healthcare professionals, clinical investigators, regulatory agencies and respected advocates in the diabetes community, including you. We have worked together to allow for this first step in the artificial pancreas pathway. Most importantly, this approval is a big win for patients today and reinforces our ongoing commitment to improving the lives of people with diabetes."
Get more information at www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite