TYRX, Inc., a leader in the commercialization of implantable medical-pharmaceutical devices, will present the first analyses of results from its AIGISRx Anti-Bacterial Envelope Retrospective Registry during the Transcatheter Cardiovascular Therapeutics (TCT 2009) meeting in San Francisco, CA.
AIGISRx is an anti-bacterial mesh envelope developed to deliver anti-microbial agents that help provide protection against infections associated with implanted pacemakers and cardioverter defibrillators. AIGISRx also securely holds a pacemaker (PM) or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body.
During TCT 2009, a poster will be presented by Dr. Heather L. Bloom, Assistant Professor of Medicine, Emory University School of Medicine and Director of Cardiac Electrophysiology Services, Atlanta VAMC.
The intent of the IRB-sanctioned, multi-centered, retrospective study is to define the implant success rate and incidence of infection, in patients implanted with cardiac rhythm management device (CRMD) and the AIGISRx.
As of August 2009, 478 patients from nine (9) contributing clinical sites have been enrolled in the study with a > 99% success rate of CRMD implantation. Of the 478 patients enrolled, 13 were excluded as they had active or immediately preceding infection present. Of the remaining 465 patients, 318 with greater than or equal to 1 follow-up visit were analyzed.
Dr. Dan Lerner, TYRX's Chief Medical Officer, noted that "when one looks at the characteristics of the patients enrolled in the AIGISRx Retrospective Registry (ARR) to-date, it is noteworthy that there is a high percentage of patients who are, according to published studies, at high risk of CRMD-related infections, with the majority of these patients undergoing device revision."