Baxter Receives 510(k) Clearance from FDA for V-Link with VitalShield, New Antimicrobial Intravascular Technology

DEERFIELD, Ill. -- Baxter Healthcare Corporation announces 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 bloodstream 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 Baxters 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 bloodstream 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.

Many hospitalized patients need a steady supply of medications or fluids delivered into their bloodstream. Typically, an IV catheter is placed in a patients vein to allow direct access to the bloodstream. 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 patients bloodstream. 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 microorganisms. The silver antimicrobial agent helps prevent the contamination and growth of these pathogens within the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The V-Link LAD with VitalShield protective coating is the first introduction of Baxters newly developed Vital Infusion Systems product line a new integrated portfolio of products developed to promote safety and reliability, and decrease risks associated with IV therapy.

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. There are several types of healthcare-associated infections of these, bloodstream infections are the most costly and life-threatening, resulting in an increase in mortality rate of 18 percent when compared to patients without a bloodstream infection. Leading researchers have estimated that more than 400,000 bloodstream infections occur each year in the U.S. alone. Healthcare-acquired bloodstream infections cost an average of $34,000 in increased direct hospital costs and can increase patient length-of-stays by 23 days. Many hospitals and other healthcare facilities have developed extensive control programs to prevent the occurrence of infections. Even when clinicians in hospitals do their best to practice good hygiene techniques, the risk of pathogen contamination may still persist.

Source: Baxter Healthcare Corporation