New Innovation Demonstrates Reductions in Flow Interruptions, Including Silent Occlusions
BD Medical, a segment of leading global medical technology company BD (Becton, Dickinson and Company) (NYSE: BDX), and Medtronic (NYSE: MDT) today announced a collaboration to introduce a new insulin pump infusion set with BD FlowSmart™ technology. An insulin infusion set delivers insulin from the pump to the body and is a critical part of the overall pump system. As part of the agreement, Medtronic will commercialize the infusion set, while BD will manufacture the product. This agreement represents an important collaboration between two leading diabetes device companies uniting to address unmet needs and improve infusion set options for people with diabetes using insulin pumps.
The infusion set recently received both FDA clearance (April 2015) and Health Canada approval (January 2015) and is expected to be launched in 2016. An application has been submitted for CE marking. It is designed to work with both Medtronic insulin pumps and most other manufacturers' insulin pumps.
"We are very excited to partner with a global leader like Medtronic to ensure that the benefits of
BD FlowSmart technology can be made widely available to as many people living with diabetes as possible," said Kenneth Miller, Worldwide President, BD Medical-Diabetes Care. "By increasing the reach and availability of this technology, we have an opportunity to enhance the use of insulin pump therapy by providing potentially more consistent insulin delivery and fewer flow interruptions. This technology is an extension of BD's long-standing commitment to deliver injection solutions, and builds on previous BD research that has advanced the science and understanding of insulin delivery as well as patient comfort."
"Medtronic is committed to advancing innovation across the entire insulin pump system, including infusion sets, to improve outcomes and expand options to satisfy different patient needs, body types and lifestyles," said Annette Bruls, Vice-President and General Manager, Diabetes Service and Solutions at Medtronic. "Our partnering with diabetes technology leaders, such as BD, will give more people with diabetes access to these innovations so they can enjoy greater freedom and better health."
The insulin infusion set with BD FlowSmart technology was developed in collaboration with JDRF and The Leona M. and Harry B. Helmsley Charitable Trust to improve the treatment of type 1 diabetes.
"JDRF is thrilled to have partnered with BD and the Helmsley Charitable Trust to bring the insulin infusion set with BD FlowSmart technology to people with type 1 diabetes," said Aaron Kowalski, Ph.D., Chief Mission Officer for JDRF. "This new infusion set is an important step forward in improving insulin pump therapy, and we hope ultimately, artificial pancreas systems."
"There is an urgent need to improve the daily conditions of those living with type 1 diabetes, a disease that can take a slow but devastating toll on the millions suffering from it," said David Panzirer, trustee of the Helmsley Charitable Trust. "We are tremendously proud that, together with JDRF, our support for BD has helped to accelerate this important infusion set technology, and we look forward to the ways that today's new collaboration with Medtronic will help to bring it into the hands of people living with the disease every day."
The insulin infusion set with BD FlowSmart technology features a unique side-ported catheter designed to improve insulin flow, potentially reducing the number of flow interruptions – defined as a continuous rise in inline pressure lasting at least 30 minutesi,ii. Without triggering a pump occlusion alarm, these events are known as silent occlusions, and because pump users may be unaware of these lapses in insulin flow, they could lead to unexplained hyperglycemia in some people on pump therapy. This infusion set also features the smallest insertion needle (30 gauge) currently available, which is designed to reduce insertion pain.
Three different studies, each based on the infusion set with BD FlowSmart technology, were presented at the American Diabetes Association's 75th Scientific Sessions this past weekendiii,iv,v. Both preclinical and clinical data showed that an insulin infusion set with BD FlowSmart technology significantly reduced flow interruptions, including silent occlusions, compared to other commonly used infusion sets.
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