Summary
This study examined rates of biventricular defibrillator infection in patients who have the antibacterial envelope inserted during their implantation procedure.
Extremely low 90-day cardiac device infection rates with TYRX antibacterial envelope use
New prospective data presented on 1,000 patients at 2013 Heart Rhythm Society shows over 90 percent fewer major device infections
Denver, CO (May 11, 2013): Use of TYRX, Inc.'s AIGISRx® Antibacterial Envelope reduced major infection rates by more than 90% in patients undergoing Cardiovascular Implantable Electronic Device (CIED) replacement procedures compared to similar high-risk cohorts, according to the CITADEL & CENTURION clinical study results presented on Saturday at the Late Breaking Clinical Trials session at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions.
CITADEL / CENTURION is a prospective, multicenter clinical study to evaluate the major device infection and mechanical complication rates in the 12 months after implantation, in patients at high risk for CIED infection who have their CIED implanted with an AIGISRx Antibacterial Envelope. Study patients were enrolled at 55 US centers, and were at high-risk for infection because they were undergoing a CIED replacement procedure with an implantable cardioverter-defibrillator (ICD), (CITADEL), or a cardiac resynchronization therapy (CRT) device (CENTURION). The results from a planned interim analysis of the primary endpoints for the first 1000 eligible patients after 90 days of follow up were presented by Dr. Charles A. Henrikson, the Chief of Electrophysiology at the Oregon Health Sciences University.
Key study findings include:
"CIED infections are increasing in frequency, are associated with substantial morbidity, mortality, and cost, and present significant challenges to patients and for the physicians who provide care for them," stated Charles A. Henrikson, MD, FHRS, Oregon Health Sciences University, Portland, Oregon. "The CITADEL & CENTURION are large prospective studies enrolling patients at community, academic, and VA medical centers which will provide us with useful clinical information on the use of the AIGISRx Envelope in a variety of patients who are at high risk for CIED infection." The CITADEL (NCT01043861) & CENTURION (NCT01043705) studies are registered in the ClinicalTrials.gov registry of federally and privately supported clinical trials conducted in the US and around the world.
This study was funded by TYRX, Inc.