Defibtech, LLC, is initiating a voluntary recall of 5,418 DBP-2800 Battery Packs used in the Lifeline AED^® and ReviveR AED ^TM (semi-automatic external defibrillators). This recall affects all DBP-2800 Battery Packs shipped prior to June 4, 2007. In rare instances, when the AED is used with an affected battery pack, the AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy. Defibtech determined the need for this recall after learning of four reports from end users of this malfunction during patient use.

   According to a new report by iData Research, the leading global authority in medical device and pharmaceutical market research, the U.S. cardiac rhythm management (CRM), electrophysiology and ablation device market is estimated at $8.1 billion, with expected growth to over $12 billion by 2016.

   Increased incidence of cardiac disease and improved diagnostic technology will drive growth in cardiac ablation and electrophysiology procedures, the combined markets for which are expected to reach over $1 billion by 2016. Steerable electrophysiology catheters are expected to cannibalize the fixed-curve market. In addition, the external cardiac defibrillator market, especially automated
external defibrillators, is expected to benefit from state legislation changes that mandate their placement in schools, public buildings and certain types of workplaces across the U.S.

   TYRX, Inc. announced that it has successfully implanted its AIGISRx device in 10,000 patients in the United States. The AIGISRx device is an antibacterial mesh technology that securely holds a pacemaker (PM) or implantable cardioverter defibrillator (ICD) in place to create a stable environment, while delivering antimicrobial agents, rifampin and minocycline. These antimicrobial agents have been shown to reduce infections associated with medical devices in multiple randomized controlled trials.

   AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems, announced that it received clearance from the FDA for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system. The AtriClip system is designed to safely and effectively exclude the left atrial appendage. Initial launch in the United States is anticipated to begin later this month with full commercial release planned during the third quarter of 2010.

    “Clearance of the AtriClip system in the United States represents a major product and clinical milestone for AtriCure,” said David J. Drachman, President and Chief Executive Officer. “We believe that the AtriClip system provides a safe and efficient method to exclude the left atrial appendage.”