Healthcare Industry News:  Baxter 

Devices FDA

 News Release - November 9, 2007

Baxter Receives 510(k) Clearance From FDA For V-Link With VitalShield, New Antimicrobial Intravascular Technology

Technology shown to kill 99.9% of specific common pathogens known to cause catheter-related blood stream infections, including MRSA

DEERFIELD, Ill., Nov. 9 (HSMN NewsFeed) -- Baxter Healthcare Corporation today 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."

About V-Link Luer-activated device with VitalShield protective coating

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 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 Baxter's 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.

About Healthcare-Associated Blood Stream Infections

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 two million Americans a year acquire healthcare-associated infections. There are several types of healthcare-associated infections -- of these, blood stream infections are the most costly and life-threatening, resulting in an increase in mortality rate of 18 percent when compared to patients without a blood stream infection. Leading researchers have estimated that more than 400,000 blood stream infections occur each year in the U.S. alone. Healthcare-acquired blood stream 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.

About Medication Delivery

For more than 75 years, Baxter has pioneered products designed to help reduce errors throughout the medication management process by improving the interface between technology and clinicians. For example, to help prevent accidental needle-stick injuries, Baxter introduced the industry's first "needleless" IV access system. Baxter also set a new industry standard with the introduction of its bar code technology, the first bar code for flexible, plastic IV containers that incorporates lot number and expiration date. In the coming year, Baxter plans to introduce a new integrated portfolio of infusion pumps and administration sets, designed to promote increased security and confidence in delivery of IV medications.

About Baxter

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX ). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

This release includes forward-looking statements concerning our plans to launch V-Link with VitalShield in the U.S. and other global markets, the introduction of new products to help reduce risks associated with IV therapy and promote increased security and confidence in the delivery of IV medications and the ability of healthcare professionals to combat pathogens and make healthcare facilities safer for patients and clinicians. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: our ability to make V-Link with VitalShield and other new products available for sale in accordance with our plans; customer and market acceptance of V-Link with VitalShield and other new products; clinician practices and procedures; future actions by the FDA and other regulatory bodies and government authorities with respect to the company's infusion pumps and other new products; and other risks identified in Baxter International Inc.'s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.

Source: Baxter

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