FDA News

FDA Gives 510(k) Clearance to Baxter's New Antimicrobial Intravascular Technology

(Nov 10, 2007)-- Baxter Healthcare Corporation announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its V-Link Luer-activated device (LAD) with VitalShield protective coating. V-Link with VitalShield is the first needleless IV connector containing an antimicrobial coating. This new device has been shown to kill 99.9 percent of specific common pathogens (infection- causing microorganisms) 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 that MRSA infections cause an estimated 18,650 deaths per year in the United States (U.S.), which is 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.

"We are very pleased to receive market clearance for V-Link with VitalShield, which is the first in a series of new products Baxter's Medication Delivery business will be introducing over the next year to help reduce risks associated with IV therapy. This innovative technology represents the latest achievement in Baxter's long-standing history of bringing clinical practice-changing IV systems to market," said Camille Farhat, general manager of Global Infusion Systems, part of Baxter's Medication Delivery business. "We believe this technology will provide healthcare professionals with a greater ability to combat pathogens and make healthcare facilities safer environments for patients and clinicians."

"Catheter-related blood stream infections are a daunting challenge for the global healthcare system," states Dennis G. Maki, MD, 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."

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