ViaValve Safety I.V. Catheter Receives 510(k) Clearance from the U.S. FDA
New peripheral intravenous catheter designed to reduce risk of infection and cross contamination caused by blood exposure during I.V. starts
Smiths Medical, a leading global medical device manufacturer, announced on April 23 that its ViaValve Safety I.V. Catheter has been cleared by the U.S. Food and Drug Administration (FDA) and can be marketed in the United States. The ViaValve catheter is designed to enhance clinician and patient safety by helping reduce the risk of both blood exposure and needlestick injury and will be available for sale by the end of Summer 2012.
The ViaValve Safety I.V. Catheter can help reduce the risk of blood exposure by means of an integrated valve in the catheter hub. The valve provides blood control by impeding the backflow of blood from the patient’s vein upon initial venipuncture. This helps to prevent the transfer of bloodborne pathogens from patient to caregiver on soiled gloves, clothing, bedding and dressings by maintaining a clean access site. ViaValve Safety I.V. Catheter also helps prevent inadvertent needlesticks, which, each year, affect approximately 800,000 hospital-based healthcare workers in the U.S.
For nearly 20 years, Smiths Medical’s Jelco safety I.V. catheters have provided needlestick protection consistent with legislation driven by the U.S. Needlestick Safety and Prevention ACT and OSHA’s bloodborne pathogens standards (29 CFR 1910.1030). FDA 510(k) clearance of ViaValve(TM) Safety I.V. Catheter will allow the company to market a catheter that could help advance I.V. catheter safety by establishing an even higher standard of safety with requirements for blood control.
“We are pleased to add a solution that helps to reduce bloodborne infections during I.V. starts,” said Tommy Johns, vice president Global Product Management. “The ViaValve Safety I.V. Catheter is the latest advancement in I.V. safety, and is built on the proven Jelco catheter platform that has been a favorite of clinicians for almost two decades. It is our objective to produce innovative medical products with the purpose of promoting patient, clinician and healthcare worker safety while supporting the best possible clinical outcome.”
Product(s) described may not be licensed or available for sale in all countries. The ViaValve catheter is FDA 510(k) cleared in the U.S.
About Smiths Medical
Smiths Medical is a leading supplier of specialist medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. It is part of Smiths Group, a global leader in applying advanced technologies for markets in threat and contraband detection, energy, medical devices, communications and engineered components.