The FDA has cleared the new t:flex Insulin Pump (Tandem Diabetes Care, Inc.) for marketing in the United States, according to a press release from the manufacturer.
The t:flex Insulin Pump is indicated for the subcutaneous delivery of insulin for management of diabetes in patients aged 12 years and older. Designed for people with diabetes who require more than 100 units of U-100 insulin daily, such as adolescents with type 1 diabetes and some with type 2 diabetes, the large capacity of the device’s insulin reservoir precludes the need for frequent reservoir changes that are needed with 200-unit and 300-unit capacity pumps.
At 480 units, the device offers the largest insulin reservoir capacity currently available in the U.S., according to the release.
Tandem Diabetes Care, Inc. also manufactures the t:slim Insulin Pump.
“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. The first expansion of our product portfolio reflects our ongoing commitment to deliver user-friendly products that address unmet needs in the diabetes community,” Kim Blickenstaff, president and CEO of Tandem Diabetes Care, said in the release.
The t:flex Insulin Pump is expected to launch in the second quarter of 2015. More information can be found at www.tandemdiabetes.com/tflex.