Home Medtronic Submits IPO Prospectus for MiniMed 670G 'Artificial Pancreas' Following FDA Premarket Approval

Medtronic Submits IPO Prospectus for MiniMed 670G 'Artificial Pancreas' Following FDA Premarket Approval

Jul 02, 2016 08:00 CST Updated 08:00

VCBeat learned from the medical technology services giant, U.S.-based Medtronic Inc., that they haveFDANew Products Submitted for ReviewMiniMed 670G“Artificial pancreas” has received pre-market approval.MiniMed 670G“The artificial pancreas” can automatically track and regulate blood glucose levels in patients with diabetes, and the Federal Safety Supervision Department is expected to make a final decision within one year.


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MiniMed 670G"Artificial Pancreas" Every5Measure blood glucose every minute to ensure that patients' blood glucose levels remain within a safe range. Medtronic is124clinical trials conducted on patients revealed that,58%of the patient'sHbA1cAverage blood glucose levels from the initial7.4decreased to6.9. Compared with traditional methods of blood glucose and insulin control,MiniMed 670G“Artificial Pancreas” Can Better Control Patients’ Blood Glucose Levels. According to the Chief Investigator at the International Diabetes Center Richard BergenstalIt was revealed that the artificial pancreas has not yet experienced any dangerous events, such as device malfunction, hyperglycemia or hypoglycemia in patients, or critical hospitalization.


Patients usingMiniMed 670GAt that time, although each12The device needs to be calibrated once every hour, and the blood glucose sensor needs to be adjusted once a week.3Insulin needs to be refilled into the reservoir once a day, but compared with the traditional method of hourly finger-prick blood glucose testing, Medtronic has made significant advances in blood glucose management technology.


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According toBergenstalIntroduction: “Our work is not yet fully complete, but we have already significantly reduced the cumbersome monitoring processes for patients. They one day”24"...are monitoring their blood glucose levels around the clock, so our next goal is to help them manage diabetes without requiring real-time worry."


Medtronic Diabetes DirectorFrancine Kaufmanstated that patients can stay at home and live their normal lives without the need for remote monitoring to manage their condition.


Clinical trials have shown that patients highly favorMiniMed 670G, and toFDAApplied for continued use rights. In addition, there are100Multiple volunteers participated in the follow-up review of the study.


“This is so exciting!” said a patient who volunteered to participate in the follow-up review. “I have better conditions to manage my condition. I am learning more about this new artificial pancreas, and I will be able to use it more skillfully in the future.”


Original Source:www.massdevice.com