BD Receives FDA Clearance for a Novel Infusion Set with BD FlowSmart™ Technology to Enhance the Use of Insulin Pumps
Unique Side-Ported Catheter Designed to Offer Consistent Insulin Delivery and Fewer Flow Interruptions including Silent Occlusions
Infusion Set Developed in Collaboration with JDRF and Helmsley Charitable Trust
FRANKLIN LAKES, N.J., May 13, 2015 /PRNewswire/ -- BD Medical, a segment of leading global medical technology company BD (Becton, Dickinson and Company) (NYSE: BDX), announced today it has received 510(k) clearance from the U.S. Food and Drug Administration for a new insulin infusion set with BD FlowSmart™ technology. Insulin infusion sets connect the insulin pump to the body. The new product is BD's first within the diabetes infusion set category. BD FlowSmart features a unique side-ported catheter designed to improve insulin flow, potentially reducing the number of flow interruptions – defined as a continuous rise in pressure lasting at least 30 minutesi,ii. Without triggering an occlusion alarm, these events are known as silent occlusions, which could lead to unexplained hyperglycemia in some patientsi,ii. This infusion set also features the smallest insertion needle, designed to reduce insertion pain and trauma. The product is expected to launch in the U.S. in fiscal year 2016.
BD collaborated with JDRF and The Leona M. and Harry B. Helmsley Charitable Trust on the research and development of the new infusion set to enhance the use of insulin pumps and improve the treatment of type 1 diabetes. Approximately two thirds of current insulin pump users have been shown to experience insulin flow interruptions that often go undetected by the pump occlusion alarm system.iii
"We believe that our new infusion set with BD FlowSmart technology is a ground-breaking innovation in diabetes technology that redefines the role of infusion sets in pump therapy by reducing the incidence of silent occlusions," said Kenneth Miller, Worldwide President, BD Medical-Diabetes Care. "We are especially pleased to achieve this milestone in collaboration with JDRF and the Helmsley Charitable Trust, and that our work together may help people better control their diabetes."
"JDRF is excited to see the potential of BD's new infusion set for people with type 1 diabetes," said Derek Rapp, JDRF President & CEO. "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 help 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."
"Now more than ever before, we believe that philanthropy is uniquely positioned to partner with industry to help incentivize and catalyze the development of new therapies and treatments for people with type 1 diabetes," said David Panzirer, trustee of the Helmsley Charitable Trust. "We are thrilled that, together with JDRF, our support for BD has helped move this important infusion technology from the early conceptual stages to an FDA-approved device that can have a real, tangible impact on those living with type 1 diabetes every day."
In a previously presented head-to-head clinical study with a leading infusion set, subjects using the infusion set with BD FlowSmart technology had significantly fewer flow interruptions and less time spent with interrupted flow.ii Three studies featuring the new infusion set with BD FlowSmart technology will be presented during the American Diabetes Association's annual meeting in Boston from June 5-9, 2015.
The infusion set with BD FlowSmart technology received approval for sale in Canada (January 2015) and United States (April 2015). An application has been submitted for CE marking and a response is anticipated from the Notified Body in May 2015.
Product availability is expected in fiscal year 2016. To register for more information, please visit www.bd.com/infusionset.
BD is a leading medical technology company that partners with customers and stakeholders to address many of the world's most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes. We are more than 45,000 associates in 50 countries who strive to fulfill our purpose of "Helping all people live healthy lives" by advancing the quality, accessibility, safety and affordability of healthcare around the world. In 2015, BD welcomed CareFusion and its products into the BD family of solutions. For more information on BD, please visit www.bd.com.
JDRF is the leading global organization focused on type 1 diabetes (T1D) research. JDRF's goal is to progressively remove the impact of T1D from people's lives until we achieve a world without T1D. JDRF collaborates with a wide spectrum of partners and is the only organization with the scientific resources, policy influence and a working plan to bring life-changing therapies from the lab to the community. As the largest charitable supporter of T1D research, JDRF has invested nearly $2B in research over the past 45 years and is sponsoring scientific research in 17 countries worldwide. For more information, please visit jdrf.org.
About the Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional nonprofits and other mission-aligned organizations in health, selected place-based initiatives, and education and human services. Since 2008, when the Trust began its active grantmaking, it has committed more than $1 billion. The Helmsley Type 1 Diabetes Program is the largest private foundation funder of T1D in the nation focused on understanding the disease, developing better treatments and improving care and access. For more information, visit http://helmsleytrust.org/.
i Bolick, Natasha, et al. "Reduction of Silent Occlusion Occurrence During Continuous Subcutaneous Insulin Infusion." ATTD. Paris, France, 2015.
ii Gibney M, et al. Continuous Subcutaneous Insulin Infusion (CSII) sets – Reduced flow interruptions with a novel investigational catheter infusion set. Diab Tech Ther 2015 (Suppl 1);17:A-8
iii van Bon A, et al. Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: A randomized controlled trial. Diab Tech Ther 2011;13(6):607-614
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/bd-receives-fda-clearance-for-a-novel-infusion-set-with-bd-flowsmart-technology-to-enhance-the-use-of-insulin-pumps-300082370.html
Released May 13, 2015