ViaValve Safety IV Catheter Receives 510(k) FDA Clearance, Marketing Starts

Officials from Smiths Medical announce that the company’s ViaValve Safety IV Catheter has received clearance by the U.S. Food and Drug Administration (FDA) and can begin marketing in the United States. Design of the ViaValve catheter is 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 IV 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 IV 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 IV 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 Safety IV Catheter will allow the company to market a catheter that could help advance IV catheter safety by establishing an even higher standard of safety with requirements for blood control.

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"We are pleased to add a solution that helps to reduce bloodborne infections during IV starts," says Tommy Johns, vice president global product management. "The ViaValve Safety IV Catheter is the latest advancement in IV 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.