Baxter's Antimicrobial IV Technology Now Shown To Kill Six Common Pathogens, Including MRSA And VRE

Main Category: MRSA / Drug Resistance
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 30 Sep 2008 - 0:00 PDT

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Baxter Healthcare Corporation announced that it received 510(k) clearance for expanded labeling for the first antimicrobial needleless intravenous (IV) connector, V-Link Luer-activated device (LAD) with VitalShield protective coating. With a new federal policy restricting reimbursement for healthcare-associated infections (HAIs) taking effect on October 1, healthcare professionals are seeking effective techniques and technologies to reduce the risk of contamination from a broad array of pathogens (infection-causing agents) within their hospitals.

Launched earlier this year, V-Link with VitalShield has now been shown to kill at least 99.99 percent of six common pathogens known to cause catheter-related bloodstream infections. The U.S. Food and Drug Administration (FDA) cleared expanded labeling for V-Link with VitalShield based on V-Link's ability to combat three additional pathogens: vancomycin-resistant Enterococcus faecalis (VRE), Escherichia coli (E. coli) and Staphylococcus epidermidis (coagulase negative). These three pathogens improve upon the previously cleared labeling, which included methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Enterobacter cloacae.

Testing has demonstrated V-Link with VitalShield is effective against this broad spectrum of microorganisms and retains antimicrobial efficacy for up to a 96-hour period. In vitro testing for V-Link with VitalShield was conducted using six strains of six common pathogens known to cause bloodstream infections. V-Link with VitalShield is already available in the United States, Canada, Puerto Rico, Australia and New Zealand, and Baxter plans to launch the product in Europe later this year.

V-Link with VitalShield's expanded indications for use include VRE, a multi-drug resistant organism, which over the past 20 years has been increasingly reported as a source of healthcare-associated infections.(1,2) Pathogens such as VRE and MRSA can contaminate medical devices used to deliver IV fluids and medication to patients. The V-Link device is uniquely coated on both inner and outer surfaces with a proprietary silver-based antimicrobial technology, VitalShield, which helps to prevent contamination and growth of these pathogens within the device.

"The revised labeling and expanded indications for use further validate the broad spectrum antimicrobial coverage and effectiveness of V-Link with VitalShield in lowering the risk of pathogen contamination," said Francois Lebel, MD, vice president of Clinical and Medical Affairs for Baxter's Medication Delivery business. "This additional microbial coverage and long-lasting effect give healthcare professionals added confidence that they are taking extra precaution to address patient safety."

"Bacteria can contaminate needleless IV connectors, particularly if healthcare workers do not adhere to proper infection prevention measures. In my practice, we have begun to evaluate this device and hope to see if its use leads to lower bloodstream infection rates," said James Steinberg, MD, associate professor of medicine in the Division of Infectious Diseases at Emory University School of Medicine.

Starting this October, the Centers for Medicare and Medicaid Services (CMS) will no longer reimburse U.S. hospitals for costs required to treat healthcare-associated infections, including catheter-related bloodstream infections. As the new CMS policy takes effect, healthcare facilities will look to adopt infection control strategies to improve patient care and avoid financial penalties.

V-Link with VitalShield Data Results to be Shared at ICAAC/IDSA

Baxter announced today that study results for V-Link with VitalShield will be presented on October 27 during the first-ever joint meeting of the American Society for Microbiology and the Infectious Diseases Society of America (48th Annual ICAAC/IDSA 46th Annual Meeting) in Washington, DC. The study reviews the effectiveness of V-Link with VitalShield in an in vivo model of MRSA-generated catheter-related bloodstream infection and will be presented by Mark Rupp, MD, medical director and professor of infectious disease at the University of Nebraska Medical Center.

"Catheter-related bloodstream infections are clinically significant infections with broad implications for both patients and our healthcare system," said Dr. Rupp. "The data I am presenting at the ICAAC/IDSA meeting indicate that this silver-coated catheter connector valve may provide a protective effect against MRSA."

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

Many hospitalized patients need a steady supply of medications or fluids delivered into their bloodstream. Typically, an IV catheter is placed in a patient's 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 specific pathogens within the device at the point of entry to the patient's bloodstream. Reduction in colonization or microbial growth on the device has not yet been studied to substantiate a reduction in bloodstream infections. Silver is a well-known antimicrobial agent, and the V-Link device is coated on both inner and outer surfaces with a specially designed formulation, VitalShield, which 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.

V-Link with VitalShield is the first introduction of Baxter's newly developed Vital Infusion Systems product line -- an integrated portfolio of products developed to promote safety and reliability, and decrease risks associated with IV therapy.

About Healthcare Associated Bloodstream Infections

Researchers have estimated that more than 400,000 vascular catheter-related bloodstream infections occur each year in the United States alone.(3) The Centers for Disease Control and Prevention (CDC) reported in 2007 that MRSA infections cause an estimated 18,650 deaths per year in the U.S., which are more per year than is caused in the U.S. by HIV/AIDS.(4,5) In 2004, VRE caused approximately one out of every three infections in hospital intensive-care units, according to the CDC.(6) There are several types of healthcare-associated infections -- of these, bloodstream infections are the most costly and life-threatening, resulting in an average increase in mortality rate of 18 percent when compared to patients without a bloodstream infection.(7,8,9) According to U.S. estimates, healthcare-associated bloodstream infections cost an average of $34,000 in increased direct hospital costs and can increase patient length-of-stays by 23 days.(10,11)

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 potential device contamination by pathogens may still persist.

About Baxter

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the potential of V-Link with VitalShield to impact catheter-related infections and Baxter's intention to launch V-Link with VitalShield in Europe later this year. 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: the effect of V-Link with VitalShield on catheter-related infections; our ability to make V-Link with VitalShield and other new products, including those associated with the Vital Infusion Systems product line, available for sale in accordance with our plans; customer and market acceptance of V-Link with VitalShield, products associated with the Vital Infusion Systems product line 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 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.

References

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2. Lee P, Ferguson D, Laffan J. Vancomycin-Resistant Enterococcus Avium Infections. Infectious Diseases in Clinical Practice, 2004; 12(4): 239-244.

3. Raad I. Intravascular-Catheter-Related Infections. Lancet, 1998; 351: 893-98

4. Klevens, et al. Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States. JAMA, 2007; 298(15): 1763-1771.

5. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report: Cases of HIV Infection and AIDS in the United States and Dependent Areas. 2005: 16-17.

6. National Institute of Allergy and Infectious Diseases. Antimicrobial (Drug) Resistance -- Vancomycin-Resistant Enterococci (VRE) Overview. Retrieved June 10, 2008.

7. Stone W, Braccia D, Larson E. Systematic Review of Economic Analyses of Health care-associated Infections. Am J Infect Control, 2005; 33: 501-509.

8. Infection Control in the Intensive Care Unit -- Second Edition. Springer Milan; 2005.

9. Berenholtz S, et al. Eliminating Catheter-related Bloodstream Infections in the Intensive Care Unit. Crit Care Med, 2004; 32(10): 2014-2020.

10. DiGiovine B, et al. The Attributable Mortality and Costs of Primary Nosocomial Bloodstream Infections in the Intensive Care Unit. Am J Respir Crit Care Med, 1999; 160: 976-981.

11. Pennsylvania Health Care Cost Containment Council. Hospital-acquired Infections in Pennsylvania. November 2006.

Baxter Healthcare Corporation
http://www.baxter.com