FOR IMMEDIATE RELEASE
CleoTM 90 Infusion Set from Smiths Medical Gains FDA Clearance
St. Paul, MN, October 18, 2004 - Smiths Medical MD, Inc. announced today it has received 510(k) Pre-market Notification market clearance from the U.S. Food and Drug Administration (FDA) for its new subcutaneous infusion set product, the CleoTM 90 infusion set. Infusion sets are a key element of an insulin pump system, delivering insulin in a flow path connection between the pump and its wearer.
The all-in-one design of the CleoTM 90 infusion set features an automatic needle retraction system to reduce unwanted needlesticks, a skin-like adhesive dressing that breathes yet keeps water out, and a hidden insertion needle aiding insertions with small children and those with needle-phobia. The 360 degree site connectivity option provides total tubing direction control, allowing users to wear what they want, when they want. The CleoTM 90 infusion set is planned for release to customers in the spring of 2005.
"Our investment in developing this truly unique infusion set product demonstrates our commitment to improving the lives of those with diabetes," said Rod Kellogg, Vice President and General Manager of the Diabetes Division at Smiths Medical. "I am proud to add this new infusion set to our portfolio of products for the diabetes market, which includes our highly successful CozMoreTM Insulin Technology System."
Smiths Medical MD, Inc. is a world leader in the design, manufacture, and distribution of medical devices used in infusion therapy, including ambulatory infusion pumps, large volume infusion pumps, implantable access systems, dialysis and infusion catheters, needles, and insulin delivery systems. Headquartered in St. Paul, Minn., Smiths Medical MD (Medication Delivery) is part of Smiths Group plc, London, and is committed to developing the highest quality, most reliable products to provide innovative, convenient, and cost-effective drug delivery worldwide. For more information visit www.cleoinfusionsets.com.
Contact: Terri Servais
Phone: (651) 628-7248
The Cleo Infusion Set
Last Updated: Tuesday October 19, 2004 09:12:06
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