Tandem Diabetes Care, a medical device company, on Monday
announced that the U.S. Food and Drug Administration (FDA) has granted the
clearance to market the t:flex Insulin Pump.
At 480 units, the insulin reservoir of the t:flex Pump has the largest capacity currently available in the United States.
"In recognizing that one size does not fit all, the t:flex Pump was developed using Tandem's proprietary technology platform to bring t:slim's benefits to people with greater insulin needs. This first expansion of our product portfolio reflects our ongoing commitment to deliver user-friendly products that address unmet needs in the diabetes community," said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care.
The t:flex is expected to launch in the US in the second quarter of 2015.
Diabetes is a chronic, life-threatening disease that affects more than 29 million people in the United States. More than 3 million people in the United States require daily administration of insulin and are candidates for pump therapy. Around 400,000 Americans with type 1 diabetes use an insulin pump, or approximately 27% of the type 1 diabetes population. In addition, approximately 75,000 Americans with type 2 diabetes use an insulin pump, a small fraction of the type 2 diabetes population.
Recent studies show that insulin pump therapy reduces average blood glucose levels and overall insulin needs in people with type 2 diabetes compared with standard therapy using multiple daily injections (2). According to a research, two-thirds of endocrinologists cited limited capacity as the number one barrier to insulin pump adoption for people with type 2 diabetes who are insulin dependent.