The FDA has granted 510(k) clearance to BD Medical for a new insulin infusion set with BD FlowSmart technology for patients with diabetes, according to a press release from the manufacturer.
BD FlowSmart features a side-ported catheter designed to improve insulin flow, which may decrease the number of flow interruptions, defined as a continuous rise in pressure lasting at least 30 minutes. These events, also known as silent occlusions, could lead to unexplained hyperglycemia in some patients. The infusion set also includes the smallest insertion needle, the release states.
In a head-to-head clinical study with another infusion set, data showed that participants using the insulin infusion set with BD FlowSmart technology experienced significantly fewer flow interruptions and less time spent with interrupted flow, according to the release. Three studies of the new infusion set will also be presented at the 2015 American Diabetes Association’s 75th Scientific Sessions in Boston.
BD collaborated with the JDRF and The Leona M. and Harry B. Helmsley Charitable Trust for the research and development of the new insulin infusion set to improve the treatment of type 1 diabetes.
“JDRF is excited to see the potential of BD’s new infusion set for people with type 1 diabetes,” Derek Rapp, JDRF President and CEO, said in the release.
“Experiencing hyperglycemia for even a short period of time can lead to disastrous consequences such as ketoacidosis, and over long periods of time, concerns of serious complications are a major part of living with type 1 diabetes for many people. Having the assurance of this new technology in the arsenal of tools to relieve the daily burden of type 1 diabetes is very encouraging. It’s a privilege to work with such dedicated organizations like the Helmsley Charitable Trust and BD in helping to change the understanding and treatment of this disease.”
Currently, the insulin infusion set with BD FlowSmart technology has received approval for sale in Canada and the United States, and an application has also been submitted for CE marking.
The new infusion set is expected to launch in the United States in fiscal year 2016.