Surgery News - February 2008 - (Page 11)

F E B R U A RY 2 0 0 8 • SURGERY NEWS DRUG DEVELOPMENTS NEW INDICATIONS & APPROVALS 11 Voluven, Agento IC Silver-Coated Endotracheal Tube Voluven (Fresenius Kabi) A plasma volume substitute (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) approved by the Food and Drug Administration for the treatment and prevention of hypovolemia. Recommended Dosage: Administered by intravenous infusion at a daily dose and rate based on blood loss, hemodynamics, and hemodilution effects. Some clinical data including dosing are available in newborns and infants under age 2. Special Considerations: Nausea and itching were the most common side effects, according to the FDA. Anaphylactoid reactions have been reported. Contraindicated in patients with known hypersensitivity to hydroxyethyl starch, fluid overload, renal failure with oliguria or anuria not related to hypovolemia, severe hypernatremia or severe hyperchloremia, and intracranial bleeding; and in patients on dialysis. The manufacturer has agreed to conduct studies in patients with severe sepsis and in patients aged 2-12 during open heart surgery. Comment: Voluven contains a synthetic starch in a colloidal solution. Since becoming available in Europe in 1999, more than 14 million units of the product have been sold worldwide, said a spokesman for Fresenius Kabi, a German company. It has been compared with other colloidal plasma substitutes in studies of pediatric and adult surgical patients and in patients in intensive care, for treating hypovolemia before, during, or after surgery, and to prevent hypovolemia in patients undergoing autologous blood donation, hypervolemic hemodilution before cardiac surgery, and acute normovolemic hemodilution. From 500 mL to 4,500 mL/day is administered perioperatively. A U.S. trial comparing Voluven with Hespan (hetastarch) in 100 orthopedic surgery patients found that both were equally safe and effective in expanding blood volume during surgery. In a study of 82 newborns and infants undergoing elective surgery, it was as safe and effective as human 5% serum albumin. The approval “provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups,” Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement announcing the approval in late December 2007. Agento IC silver-coated endotracheal tube (C.R. Bard Inc.) An endotracheal tube coated with a thin film of silver indicated for airway management by oral or nasal intubation of the trachea for anesthesia and when intubation is expected to last 24 hours or more, or may be unpredictable. This is the first endotracheal tube coated with silver, which is known to have antimicrobial properties, according to the FDA statement announcing the approval. Special Considerations: FDA clearance of this device includes the claim that it “has been shown to reduce the incidence of microbiologically confirmed ventilator-associated pneumonia (VAP) in patients intubated for 24 hours or longer.” Comment: In a randomized, multicenter clinical trial of hospitalized patients receiving mechanical ventilation, the incidence of VAP was 4.8% in the silver-coated ET tube group, versus 7.5% in the uncoated ET tube group—a 36% reduction, according to the FDA. The use of the silver-coated ET tube delayed the time to onset of microbiologically confirmed VAP. “This product can help lower this risk” of pneumonia in patients who need to be on ventilators, Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said in the statement. The tube was cleared for marketing, which means it was shown to be “substantially equivalent” to another device that is marketed for similar indications and has similar technological characteristics and principles of operation, which is how many devices enter the market and is a less stringent standard than approval. The device, launched in December 2007, uses the company’s proprietary silver colloid polymer technology, “which allows the tube to elute microbicidal levels of silver ions,” according to Bard, the manufacturer. —Elizabeth Mechcatie New InfoV.A.C. Therapy System ® Better by Design The Next Generation of V.A.C.® Therapy The InfoV.A.C.® Therapy System delivers the same positive outcomes you trust – but is now simpler and more efficient than ever.* Easier to Use. Designed with busy clinicians in mind. Simpler Training. Designed to be easier to learn, improving proficiency. Better Information. Designed to provide consistent wound progress tracking. Better by Design www.InfoVACTherapy.com • 1-800-275-4524 *As compared to V.A.C. ATS® Therapy Note: Specific indications, contraindications, warnings, precautions, and safety tips exist for this product and therapy. Please consult Product Instructions for Use prior to applications. ©2008 KCI Licensing, Inc. All rights reserved. KCI USA, 8023 Vantage Drive, San Antonio, TX 78230. All trademarks and service marks designated herein are the property of KCI and its affiliates and licensors. The V.A.C.® (Vacuum Assisted Closure®) System and most KCI products are subject to patents and/or pending patents. http://www.InfoVACTherapy.com http://www.InfoVACTherapy.com

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Surgery News - February 2008 Contents IOM Committee Looks Into Safety Of Work Schedules Expertise Can Extend Liver Resectability Report Faults Specialty Hospitals' EDs Meeting Expectations Silver Lining HOD on Health Longer Liver Life?

Surgery News - February 2008

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