Medtronic has received federal regulatory approval for a diabetes management system that includes an insulin pump, continuous glucose monitoring and software to help patients cope with the disease.
The device giant’s MiniMed Paradigm Real-Time Revel System is capable of sending “predictive alerts” to warn patients of rapid changes in blood sugar levels, according to a statement from Medtronic.
The new diabetes management system is important to Medtronic because of the sheer size of the diabetes market. In 2007, the worldwide diabetes treatment market was pegged at $25 billion and expected to continue to grow, according to one estimate. Between 2000 and 2030, the number of diabetics worldwide is expected to more than double to 366 million, according to the World Health Organization.
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Katie Szyman, president of Medtronic’s diabetes business, said the new system takes the company one step closer to creating the “artificial pancreas,” which has long been a goal for Medtronic. That would consist of technology that continuously monitors glucose levels and automatically adjusts insulin delivery in patients with diabetes.
The Paradigm system’s insulin pump comes with a new feature for patients who are sensitive to insulin, such as children; it can now can deliver insulin in smaller increments, according to the statement. Insulin pumps have recently drawn the attention of the Food and Drug Administration, which earlier this month held a hearing to discuss risks posed by insulin-infusion pumps, after 18 recalls were issued for the devices over a five-year period.
In other Medtronic news, a second-generation pacemaker from the company that’s designed for use with MRI machines has been approved for sale in the European Union. The Advisa DR MRI SureScan pacemaker isn’t available in the U.S.
The company also said it completed a Pre-Market Approval submission to the FDA for its Arctic Front Cardiac CryoAblation Catheter System. The system is designed to treat patients with paroxysmal atrial fibrillation, an irregular quivering of the upper chambers of the heart that starts and stops on its own. The system uses freezing-cold temperatures delivered via a catheter to kill the heart tissue that’s causing the irregular quivering.
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An approved Pre-Market Approval application is essentially a private license for marketing a particular medical device, according to the FDA.
