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.
AIGISRx® Antibacterial Envelope is indicated for holding a pacemaker or implantable cardioverter-defibrillator, thereby creating a stable environment surrounding the device and leads after surgical placement. The biocompatible mesh is coated with antibiotics that elute (dissolve) within a 7 to 10 day period.
Credit: TYRX, Inc.
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:
There was 1 major infection (0.1%), the primary efficacy endpoint of the study, after 90 days of follow-up. There were 11 minor infections (limited to the incision and skin) (1.1%).
The incidence of the most common mechanical complication, major hematomas (1.5%), was not significantly different than the pre-defined control cohort (2.3%; P = NS).
This study was funded by TYRX, Inc.
About Heart Rhythm SocietyHeart Rhythm 2013 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society's Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.
For more information, please visit http://www.TYRX.com or http://www.HeartDeviceInfection.com.
*Data on file at TYRX and published Hansen et al. Pacing Clin Electrophysiol. 2009; 32(7):898-907.
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