The 510(k) clearance covers subsidiary BD Medical’s insulin infusion set using the new FlowSmart technology. This includes a side-ported catheter designed to improve insulin flow and reduce flow interruptions. BD said the infusion set also includes smaller insertion needles to help reduce patient pain and trauma.
Flow interruptions are known as silent occlusions, and can lead to unexplained hyperglycemia in some patients.
Insulin infusion sets link the insulin pump to the body; plans call for launching the new product in the 2016 fiscal year. The technology has had approval for sale in Canada since January. A CE Mark application is pending with a response anticipated sometime in May, BD said.
Research behind the updated technology stemmed from collaboration with 2 outside groups, BD said, the Juvenile Diabetes Research Foundation and The Leona M. & Harry B. Helmsley Charitable Trust.
Kenneth Miller, worldwide president of BD Medical-Diabetes Care, said in prepared remarks that the new infusion set amounts to a "ground-breaking innovation in diabetes technology that redefines the role of infusion sets in pump therapy by reducing the incidents of silent occlusions."
BD said it plans to present results from 3 studies involving the infusion set with BD FlowSmart technology during the American Diabetes Assn. annual meeting in Boston next month.