TYRX enrolls 1000th patient in CITADEL/CENTURION AIGISRx Antibacterial Envelope studies

Apr 2 2012

TYRX^®, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections (SSIs) associated with cardiovascular implantable electronic devices (CIEDs), announced today that the 1000^th patient has been enrolled into the CITADEL & CENTURION clinical studies evaluating the company's AIGISRx Antibacterial Envelope.

CITADEL & CENTURION are prospective, multicenter clinical studies, designed to enroll 4300 subjects at over 50 U.S. study sites. The studies are evaluating the use of AIGISRx in patients who are at high risk for CIED infection because their current CIED is being replaced with either an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy (CRT) device accompanied by the AIGISRx.

The primary endpoints for both studies are 1) major ICD/CRT device-related infections and 2) ICD/CRT device-related mechanical complications. Patients will be followed for 12 months, with pre-defined interim analyses at 3 and 6 months.

The AIGISRx Envelope is a mesh device that securely holds a pacemaker or ICD, creating a stable environment surrounding the device and leads after surgical placement. The biocompatible mesh is coated with antibiotic agents rifampin and minocycline, which elute over a 7 to 10 day period to help reduce infections associated with CIED implantation.

"CIED infections present substantial challenges to patients and the physicians who care for them. CITADEL & CENTURION are large prospective studies enrolling patients at community, academic, and VA medical centers. These studies are important because they will generate useful clinical information on the use of AIGISRx in a wide variety of patients at high risk for CIED infection," stated Walter Paladino, MD, FACC, St. Elizabeth Hospital, Youngstown, Ohio.

TYRX Chief Medical Officer, Daniel Lerner, MD, commented that "CIED infections are associated with substantial morbidity, mortality, and cost, and are increasing in frequency. The risk of CIED infection is significantly increased in patients who receive a replacement device. The CITADEL & CENTURION studies are large prospective studies that will provide useful data on the clinical performance of the AIGISRx in these patients."