Diabetes: Medtronic launches FDA bid for 1st automated insulin pump

insulin management

Medical device industry titan Medtronic (NYSE:MDT) filed a bid for FDA approval of its MiniMedR 530G system, which the company bills as the world’s first insulin pump that delivers and halts insulin automatically, based on sensor readings of a patient’s glucose levels.

Regulatory approval for the MiniMedR 530G would bring the market one step closer to an "artificial pancreas," a system that would require minimal patient intervention to monitor and management blood glucose and insulin levels for patients with diabetes.

Medtronic’s bit includes data from its ongoing Aspire clinical trial, which showed that diabetic patients spent less time below the low glucose threshold when using the company’s MiniMed system when compared with conventional pump therapy.

Patients using the MiniMed device also had less severe drops in blood glucose values and none of the patients were hyperglycemic at the end of observation. The device is already commercially available outside of the U.S., but is limited to investigational device use by the FDA.

"There is a clear need for new therapies that can stop insulin delivery when glucose becomes dangerously low, which could be of great benefit if a person with diabetes is asleep or unable to react," International Diabetes Center executive director Dr. Richard Bergenstal said in prepared remarks. "Reducing the amount of time spent below the low glucose threshold without rebound hyperglycemia (high blood sugar) could help people with diabetes stay in better, overall glucose control."

Hyperglycemia can results in confusion, unresponsiveness, loss of consciousness and, in rare cases, even death, according to the release. Researchers published a study in February finding that an automated on/off feature in insulin pumps could significantly reduce the severity and duration of hypoglycemia.

"We are excited about the potential to bring low glucose suspend innovation to market in the United States to meet the unmet clinical needs in the treatment of diabetes ," Medtronic diabetes business president Katie Szyman said in prepared remarks. "This PMA application is a demonstration of our commitment to advance the science and development of insulin delivery and continuous glucose monitoring systems to commercialize an artificial pancreas."

Advocates of artificial pancreas technology have been calling on the FDA to spur progress in the field, and in December 2011 the agency released a long-awaited draft guidance aimed at clearing a path for the devices to enter the U.S. market.

By then the watchdog agency already had 20 artificial pancreas systems with IDEs for study purposes, the FDA’s Artificial Pancreas Working Group & Critical Path Initiative leader Charles "Chip" Zimliki said at the time.

Minneapolis-area medical device giant Medtronic won FDA approval in October 2011 to conduct in-home trials, the second phase of the Aspire study.

The company hopes to be the first to bring automated insulin delivery technology to patients in the U.S., but it’s not alone.

PositiveID (OTC:PSID) in March touted its prototype fully synthetic glucose sensing system, which can sense and respond to glucose in human plasma.

"The development of a fully implantable glucose sensor is one of the essential requirements for the successful development of an artificial pancreas," chairman & CEO William Caragol said at the time. "We are well positioned to play a potentially significant role in making an artificial pancreas a reality for people with type 1 diabetes."

RSS From Medical Design & Outsourcing

  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]
  • Tackling chronic sinusitis by addressing underlying factors
    The stuffy noses and sinus pressure of head colds are uncomfortable, but for most people, they go away within days. For those with chronic sinusitis, however, those symptoms and others drag on for weeks. Now scientists are onto a potential new therapy that could address one of the underlying factors associated with the condition. They […]
  • Implantable “artificial pancreas” could help diabetes patients control their blood sugar
    Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Now scientists are reporting in the American Chemical Society (ACS) journal, “Industrial & Engineering Chemistry Research,” the development of an implantable “artificial pancreas” that continuously measures a person’s blood sugar or glucose level and can automatically release insulin as […]
  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]

Leave a Reply