A day after settling its patent beef with diabetes rival Insulet, Medtronic (NYSE:MDT) said the FDA granted pre-market approval for its 1st-generation artificial pancreas device, the MiniMed 530G with Enlite – alongside a warning letter from the federal watchdog agency.
Medtronic claimed the device as the 1st such system in the U.S. with the ability to stop halt glucose delivery at a preset level. The PMA nod, for diabetics age 16 and older, was accompanied by a Sept. 19 warning letter from the FDA, according to a press release.
Medtronic and other medical device makers are racing to develop the 1st true artificial pancreas systems, considered "the Holy Grail" of diabetes research. The Juvenile Diabetes Research Foundation and Becton Dickinson & Co. (NYSE:BDX) recently said they’re "accelerating" development of the technology by combining their proprietary diabetes management devices in a 3-year agreement. And Cambridge Consultants and the U.K.’s Institute of Metabolic Science said they’re also researching artificial pancreas technology at Addenbrooke’s Hospital in Cambridge, England.
The MiniMed 530G features "threshold suspension," a program which monitors and modifies insulin delivery when blood glucose readings hit preset levels, helping reduce the incidence of hypoglycemia without affecting blood sugar. In a clinical trial of nearly 250 patients with Type I diabetes and nocturnal hypoglycemia, researchers reported that acute events were 31.8% less likely in patients using the device with threshold suspension. Medtronic said it plans to begin ramping up production immediately ahead of a planned launch "in the next several weeks."
The Fridley, Minn.-based company said it’s already fixed many of the issues flagged in the FDA’s warning letter and that its PMA approval includes a commitment to "engage in direct patient follow-up" and "make certain manufacturing accommodations."
"Medtronic has already addressed many of the observations noted in the warning letter and is committed to resolving the remaining observations as quickly as possible and in accordance with the product approval requirements," according to the release.
"We’re excited to bring yet another important ‘1st’ to the United States. The MiniMed 530G with Enlite can help people gain better control of their diabetes versus multiple daily injections," Katie Szyman, president Medtronic’s diabetes business, said in prepared remarks. "We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market."
The approval comes a day after Medtronic and Insulet put to rest a patent infringement lawsuit over Insulet’s OmniPod insulin management device. The cross-licensing deal includes a 1-time payment to Medtronic that Insulet said will ultimately cost about $10 million and gives Medtronic access to patents covering "the integration or interaction of two or more of ambulatory external drug delivery pumps, blood glucose monitoring devices, infusion sets and insertion devices."
Medtronic has also begun enrolling patients in a U.S. study to evaluate a new close-looped algorithm for night-time glucose management. The FDA is classifying this as a so-called control-to-target system, or a system that doesn’t need to be managed by the patient. Medtronic called this trail a key feasibility test for its 3rd generation artificial pancreas.
The company initially filed a bid for FDA approval of its MiniMed 530G system in June 2012. The recently published trial was an at-home patient study under investigational device exemption from the FDA.