Monmouth Junction, NJ (October 19, 2010) Patients undergoing CIED (Cardiac Implantable Electronic Device) implantation with TYRX, Inc.'s FDA-cleared AIGISRx Antibacterial Envelope enjoyed a 99.5% rate of successful implantation with an overall infection rate of 0.48% in the first 1.9 months following the procedure, as reported in newly published results of TYRX's COMMAND Clinical Study. There were no infections in patients receiving initial implantations of pacemakers, implantable cardioverter-defibrillators, or cardiac resynchronization therapy devices. The infection rate within the highest risk cohort, ICD/CRT-D replacements/revisions, demonstrated 70% fewer infections than some previous studies.
Results of the COMMAND Study included data from 642 consecutive CIED implantation or revision/replacement procedures utilizing the AIGISRx Antibacterial Envelope at 10 U.S. medical centers. The results were published in the October on-line issue of Pacing and Clinical Electrophysiology, the official journal of the International Cardiac Pacing and Electrophysiology Society.
"The COMMAND Study provides additional evidence that the AIGISRx Antibacterial Envelope offers physicians an effective means for addressing the significant unmet clinical need for additional CIED infection prophylaxis as described in the American Heart Association and Heart Rhythm Society CRM Infection Guidelines published earlier this year," stated Heather Bloom, MD, Director of Electrophysiology at the Atlanta VA Medical Center, Assistant Professor of Medicine, Emory University, and lead author on the COMMAND Study report.
The COMMAND Study, the first clinical study of patients undergoing CIED implantation with the AIGISRx Antibacterial Envelope, was a retrospective cohort study in patients receiving implantation of a pacemaker, implanted cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device. The primary endpoints of the study w
|Contact: Joan Kureczka|