The U.S. Food and Drug Administration (FDA) has approved Medtronic’s MiniMed® 670G system, the first Hybrid Closed Loop insulin delivery system in the world, according to a release from the company.
“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,” says Derek Rapp, president and CEO of JDRF. “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.”
“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,” says Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic. “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.”
The system is approved for the treatment of people with type 1 diabetes 14 years of age and older with ongoing studies to expand the indication to additional patient populations.
More details can be found at http://www.medtronicdiabetes.com/products/priority-access.
Loading ...