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

Saturday, November 10, 2007 General News J E 4
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DEERFIELD, Ill., Nov. 9 Baxter HealthcareCorporation 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 firstneedleless IV connector containing an antimicrobial coating. This new devicehas been shown to kill 99.9 percent of specific common pathogens (infection-causing microorganisms) known to cause catheter-related blood streaminfections, including the highly treatment-resistant bacteria calledmethicillin-resistant Staphylococcus aureus, or MRSA. The Centers for DiseaseControl and Prevention (CDC) recently reported that MRSA infections cause anestimated 18,650 deaths per year in the United States (U.S.), which is moredeaths in the U.S. per year than HIV/AIDS.

Baxter plans to launch the V-Link device with VitalShield coating in theU.S. beginning in the first half of 2008 and will expand to global marketslater in the year.

"We are very pleased to receive market clearance for V-Link withVitalShield, which is the first in a series of new products Baxter'sMedication Delivery business will be introducing over the next year to helpreduce risks associated with IV therapy. This innovative technologyrepresents the latest achievement in Baxter's long-standing history ofbringing clinical practice-changing IV systems to market," said CamilleFarhat, general manager of Global Infusion Systems, part of Baxter'sMedication Delivery business. "We believe this technology will providehealthcare professionals with a greater ability to combat pathogens and makehealthcare facilities safer environments for patients and clinicians."

"Catheter-related blood stream infections are a daunting challenge for theglobal healthcare system," states Dennis G. Maki, MD, Ovid O. Meyer Professorof Medicine at the University of Wisconsin School of Medicine and PublicHealth. "While adherence to basic infection control practices and proceduresare essential, I believe that novel technologies for prevention are urgentlyneeded to complement these efforts and reduce risk to the lowest levelspossible."

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

Many hospitalized patients need a steady supply of medications or fluidsdelivered into their blood stream. Typically, an IV catheter is placed in apatient's vein to allow direct access to the blood stream. In the process ofinjecting medications or fluids into a sterile line, surface or otherenvironmental contaminants may be introduced. V-Link with VitalShield, aneedleless IV connector used with the catheter or IV tubing, helps to preventcontamination and growth of pathogens on the device at this point of entry tothe patient's blood stream. Reduction in colonization or microbial growth onthe device has not been shown to correlate with a reduction in infections.

V-Link is uniquely coated on both inner and outer surfaces with aproprietary silver technology, called VitalShield. Silver is a well-knownantimicrobial agent, and this specially designed formulation has been shown tobe effective against a broad spectrum of microorganisms. The silverantimicrobial agent helps prevent the contamination and growth of thesepathogens within the V-Link device. The antimicrobial agent is not intendedto be used as a treatment for existing infections.

The V-Link LAD with VitalShield protective coating is the firstintroduction of Baxter's newly developed Vital Infusion Systems product line-- a new integrated portfolio of products developed to promote safety andreliability, and decrease risks associated with IV therapy.

About Healthcare-Associated Blood Stream Infections

Healthcare-associated infections are estimated to be the fifth-leadingcause of death in the U.S., after heart disease, cancer, stroke, and pneumoniaor influenz
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