The MiniMed 670G system
Medtronic announced Wednesday that the Food and Drug Administration has approved the first artificial pancreas – more accurately described as the first hybrid closed-loop insulin delivery system for type 1 diabetes patients.
The device — MiniMed 670G —automates insulin delivery and requires lesser patient input than in the past.
The approval seems to have come much sooner than expected. In late June, Bloomberg published a story saying that the Irish company has filed a premarket approval submission with the FDA and an approval is expected within a year.
“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,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “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.”
In a press release, a senior Medtronic executive appreciated the speed with which the product was approved.
“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,” said Francine Kaufman, chief medical officer of the Diabetes Group at Medtronic, in a statement. “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.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The MiniMed 670G system features the company’s SmartGuard HCL algorithm that allows providers and patients a level of customization as well as the Guardian sensor, the first sensor with the ability to control a hybrid closed-loop system. Through this product, patients need only have to calibrate the sensor and enter meal time carb intake.
“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,” said Dr. Richard Bergenstal, principal investigator of the pivotal study and executive director of the Park Nicollet International Diabetes Center in Minneapolis, in the news release. “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.”
The hope is that through such a device, type 1 diabetes patients get better glycemic control, the lack of which can lead to severe complications and in some cases, even death. Over time, the goal is to create a fully automated system requiring no patient involvement.
Other companies also pursuing similar technology, , include Johnson & Johnson’s Animas group, Insulet and smaller startups.
Photo: Medtronic
