Inhibition of Staphylococcus aureus biofilms by a novel antibacterial envelope for use with implantable cardiac devices.

Biofilm formation on representative implantable medical devices using a known human pathogen (Staphylococcus aureus) was significantly reduced (p < 0.01) at all time points measured (24,48, and 72 hours) by employing a novel antibacterial envelope (AIGIS Rx). The result was demonstrated using a standard US Centers for Disease Control (CDC) bioreactor model and the results were confirmed by Scanning Electron Microscopy (SEM). The antibacterial envelope used in the study is coated with a proprietary combination broad spectrum antibiotics (rifampin and minocycline) embedded in a resorbable polymeric coating. The antibiotics are designed to elute out of the coating over a multi-day period for controlled, site-specific drug delivery. The infection rate for patients receiving pacemakers and defibrillators is increasing faster than the rate of new implants and the growing resistance of S. aureus strains suggests that conventional, systemic antibiotic prophylaxis may have limited future utility. Moreover, emerging evidence suggests that bacterial biofilms result in infections of implantable medical devices. These findings demonstrate the in vitro efficacy of a new means to address potential biofilm-derived Hospital Acquired Infections (HAIs) related to implantable medical devices composed of titanium inclusive of pacemakers and defibrillators by means of a locally delivered, low dose, combination antibacterial treatment.