The FDA today granted premarket approval to Medtronic (NYSE:MDT) for its MiniMed 670G ‘artificial pancreas’ hybrid closed loop system, making it the 1st system of its kind to win clearance globally.
The MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering or withholding insulin, according to an FDA release.
The newly cleared system from the Fridley, Minn.-based medical giant includes a body-attached sensor to track glucose levels under the skin, an worn insulin pump and an infusion patch connected to the pump with a catheter to deliver insulin. The device will automatically adjust insulin levels, but requires manual entry of carbohydrates consumed and approval for bolus correction recommendations.
“The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases – especially those that require day-to-day maintenance and ongoing attention. This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” FDA’s Center for Devices and Radiological Health direct Dr. Jeffrey Shuren said in an FDA prepared release.
The device features Medtronic’s SmartGuard algorithm, which the company says is the 1st step on its phased approach towards developing a fully automated, closed loop system. The MiniMed 670G also includes the company’s Guardian Sensor, a glucose sensor with a 7-day lifespan and baked in diagnostic technology to constantly monitor the sensor’s health. The system is designed to “learn” an individual’s insulin needs and take action to minimize both high and low glucose levels.
“With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes – particularly for minimizing glucose variability and maximizing time in the target range. The data from the pivotal trial were compelling and I am confident that this therapy will be well-received by both the clinical and patient community,” pivotal study principal investigator Dr. Richard Bergenstal of Minneapolis’ Park Nicollet International Diabetes Center said in a press release.
The system won approval for the treatment of individuals with type 1 diabetes ages 14 and older, with ongoing studies looking to expand the indication to additional patient populations. Medtronic said it is planning a commercial release in the spring of 2017, with “system availability increasing over time.”
“The FDA approval of the world’s first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes. We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease. We are committed to preparing for commercial launch as quickly as possible while ensuring we provide the most successful rollout of this novel therapy,” Medtronic diabetes group chief medical officer Dr. Francine Kaufman said in a prepared statement.
“This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with this chronic disease. We are very encouraged by the speed in which this groundbreaking technology was approved by the FDA, and we are proud of the role JDRF played in achieving this exciting breakthrough. Medtronic and JDRF are committed to ensuring appropriate patient access to this therapy,” JDRF prez & CEO Derek Rapp said in prepared remarks.
Regulatory approval of the system outside the U.S. is expected by the summer of 2017, Medtronic said.
