New Data in High Risk Patients Presented at ACC by Researchers from Vanderbilt Heart and Vascular Institute
CHICAGO--(BUSINESS WIRE)-- Use of TYRX, Inc.’s AIGISRx® Antibacterial Envelope significantly reduced infection rates in patients undergoing pacemaker and implantable defibrillator implants, who were at high risk of surgical infections, according to a study presented today at the American College of Cardiology 61st Annual Scientific Session in Chicago, IL.
The 20 month retrospective cohort study was presented by researchers Matthew J. Kolek, MD, William F. Dresen, MD, and Christopher R. Ellis, MD, from Vanderbilt Heart and Vascular Institute.
The study looked at infection rates experienced by 209 patients with recognized risk factors for infection (i.e. CRT systems or abandoned leads, systemic anticoagulation, diabetes, renal insufficiency, and/or fever or leukocytosis within 24 hours of implant) whose cardiac implantable electronic device (CIED) procedures included use of the implanted AIGISRx Envelope. These infection rates were compared with the infection rates experienced by a control cohort of 671 patients with matched risk factors whose CIED was implanted during the 18 month period prior to the Institute’s use of the AIGISRx Envelope.
Key findings of the study included:
- After a minimum of 90 days of follow-up, there were no ClED infections in patients who received AIGISRx implants, compared to 15 in the control group (0% vs. 2.2%, p=0.02).
- Of the 209 AIGISRx Envelopes implanted during the study period, the mean number of ClED infection risk factors was 2.8±1.2; for the 671 patient control cohort, the mean number of risk factors was 2.7±0.9.
“The incidence of CIED-related infections has risen rapidly since 2004, adding significantly to both patient mortality and health care costs,” said Dr. Ellis. “A previously reported retrospective cohort study associated use of the minocycline and rifampin-impregnated AIGISRx Envelope with low CIED infection rates, and other published studies have identified patient-specific and procedural risk factors for CIED infections. Thus we decided to examine in the context of our own institution’s experience the ability of the AIGISRx Envelope to reduce CIED infections compared to a matched cohort of control patients. Our findings clearly showed that, at our institution, patients whose CIED implantation included the use of the AIGISRx Envelope experienced a significantly lower rate of infection compared to a matched retrospective cohort of patients who underwent implantation without the antibacterial device.”
About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx® Antibacterial Envelope, designed to reduce surgical-site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in implantable pacemaker and defibrillator related endocarditis, including “superbugs” or MRSA*. Following commercial release, the AIGISRx Envelope has been used in over 25,000 patients nationwide. The company estimates that over 2% of all U.S. implantable pacemaker and defibrillator patients in 2012 will receive an AIGISRx product during their procedure.
TYRX, Inc. is an ISO 13485:2003 certified medical device manufacturer and its products utilize technology licensed exclusively from Rutgers, Baylor College of Medicine, and The University of Texas M. D. Anderson Cancer Center.
* Based upon preclinical in vitro and in vivo data. Data on file at TYRX and published in PACE 2009; 32(7) 898-907.
KEYWORDS: United States North America Illinois
INDUSTRY KEYWORDS: Health Cardiology Hospitals Medical Devices