• Ethicon (Somerville, New Jersey) said the FDA has granted an expanded indication for Evicel Fibrin Sealant (Human). The company said the product is the first fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. Evicel is the only all-human plasma-derived fibrin sealant commercially available in the U.S. It does not contain aprotinin, which has been associated with adverse effects. Evicel is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing. Evicel is contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products. Ethicon, a Johnson & Johnson company, makes surgical products for use in general surgery, wound management and women’s health & urology.

• Medtronic (Minneapolis) reported the U.S. market launch of the AneuRx AAAdvantage stent graft on the new Xcelerant hydro delivery system, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. In addition, Medtronic received FDA approval to introduce its latest generation of packaging materials for the launch of this product. The Xcelerant system will be used with the AneuRx AAAdvantage stent graft. The Xcelerant features an integrated sheath that is tapered on both ends. This dual-taper sheath is designed to facilitate insertion and retraction of the entire delivery catheter by minimizing the time that the surface area of the sheath is in contact with the artery wall. The integrated sheath also contributes to the system’s low profile characteristics, which are intended to enable excellent tracking and access through small vessels.

• SpineVision (San Francisco) said that preliminary data from an ongoing post-marketing study show that its FDA-cleared PediGuard device allows a two-fold reduction of the risk of inadvertent pedicle screw misplacement during lumbar degenerative spine surgery. In addition, the preliminary results show that the use of PediGuard leads to a six-fold reduction of medial breaches, and suggest an approximately 10% decrease in average screw-placement time, as well as a reduction of surgeons exposure to radiation by about 30%. According to the company, PediGuard is the first wireless, hand-held instrument capable of accurately detecting changes in tissue type, thus alerting surgeons to potential pedicular or vertebral breaches during pedicle screw site preparation. SpineVision makes motion preservation and fusion devices for spine specialists.

• ThromboVision (Houston) said it has initiated clinical trials of the ThromboGuide (T-Guide) platelet function monitor. The T-Guide consists of a disposable test kit and a point-of-care base unit. The system will help physicians improve their cardiac patients’ lives by individualizing antiplatelet therapy that they use to prevent heart attacks, strokes and stent occlusions. ThromboVision has licensed the patented technology developed by scientists affiliated with the Utah Artificial Heart Institute, Brigham Young University and the University of Utah. ThromboVision develops biomedical diagnostics.

• Varian (Palo Alto, California) said it has launched a new family of Pursuit columns for high performance liquid chromatography with Pursuit XRs Ultra 2.8 and Pursuit UPS 2.4. These new columns allow chromatographers to analyze samples faster while achieving higher resolution and reducing the cost per analysis, the company said. Both columns are intended for use by analytical chemists in pharmaceutical and environmental laboratories for the separation, identification and quantification of sample components. Pursuit XRs Ultra 2.8 provides enhanced speed for virtually any HPLC instrument. Optimized 2.8 micron silica particles allow chemists to increase flow rates and use a wide range of mobile phases without going above the maximum operating pressure of the instrument. Pursuit UPS 2.4 columns are designed to provide improved performance on standard “low dead-volume” HPLC systems without needing ultra-high pressures.