November 9, 2007 - Baxter Healthcare Corp. today said it received FDA 510(k) clearance for its needleless V-Link Luer-activated device (LAD), an IV connector containing a VitalShield antimicrobial coating.
The company says the new device has been shown to kill 99.9 percent of specific common pathogens known to cause catheter-related blood stream infections, including the highly treatment-resistant bacteria called Methicillin-resistant Staphylococcus aureus, or MRSA. The Centers for Disease Control and Prevention (CDC) recently reported MRSA infections cause an estimated 18,650 deaths per year in the U.S., which are more deaths in the U.S. per year than HIV/AIDS.
Baxter plans to launch the V-Link device with VitalShield coating in the U.S. beginning in the first half of 2008 and will expand to global markets later in the year.
“Catheter-related blood stream infections are a daunting challenge for the global healthcare system,” said Dennis G. Maki, M.D., Ovid O. Meyer professor of medicine at the University of Wisconsin School of Medicine and Public Health. “While adherence to basic infection control practices and procedures are essential, I believe that novel technologies for prevention are urgently needed to complement these efforts and reduce risk to the lowest levels possible.”
Many hospitalized patients need a steady supply of medications or fluids delivered into their blood stream. Typically, an IV catheter is placed in a patient’s vein to allow direct access to the blood stream. In the process of injecting medications or fluids into a sterile line, surface or other environmental contaminants may be introduced. V-Link with VitalShield, a needleless IV connector used with the catheter or IV tubing, helps to prevent contamination and growth of pathogens on the device at this point of entry to the patient’s blood stream. Reduction in colonization or microbial growth on the device has not been shown to correlate with a reduction in infections.
V-Link is uniquely coated on both inner and outer surfaces with a proprietary silver technology called VitalShield. Silver is a well-known antimicrobial agent, and this specially designed formulation has been shown to be effective against a broad spectrum of micro-organisms. The silver antimicrobial agent helps prevent the contamination and growth of these pathogens within the V-Link device.
Healthcare-associated infections are estimated to be the fifth-leading cause of death in the U.S., after heart disease, cancer, stroke, and pneumonia or influenza. The CDC estimates that nearly 2 million Americans a year acquire healthcare-associated infections.
For more information: www.baxter.com