AIGIS 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. AIGIS also securely holds a pacemaker (PM) or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body.
During the Heart Rhythm Society 2009 Annual Scientific Sessions, TYRX held an AIGIS Retrospective Registry (ARR) Investigator’s Meeting at which the study’s early results were presented and discussed. 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 AIGIS.
To date, 393 patients from seven (7) clinical sites have been enrolled in the study with a 98% success rate of CRMD implantation, with the 2% of failures not being AIGIS related. Of the 393 patients enrolled, at least one follow-up visit has been completed for 254 patients with a mean follow-up period of 59 days and a median follow-up of 32 days. Noting that De Oliveira et al report the median time to CRMD infection as 14 days, and Klug et al reported a median time to infection of 52 days.
Dr. Dan Lerner, TYRX’s Chief Medical Officer, noted that “when one looks at the characteristics of the patients enrolled in the AIGIS Retrospective Registry 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.”
Dr. Dan Lerner continued, “Of the 3 generator pocket infections reported to date, 2 occurred in patients who had prior explants for infection within the past 6 months. Importantly, these early data indicate AIGIS does not interfere with CRMD implant success. The AIGIS Retrospective Registry continues with the expectation that, with the enrollment of 3 additional clinical sites, TYRX will collect data on over 500 AIGIS patients, representing more than 15% of the 3,000 AIGIS implanted to-date. The company plans to continue the AIGIS Retrospective Registry follow-up period will provide clinicians greater insight into the clinical utility of AIGIS.”
“We are delighted these data indicate clinicians are using AIGIS in the full spectrum of CRMD implant procedures. In particular, it is gratifying to see that AIGIS is being used in patients who are at very high risk for CRMD infection,” added Bill Edelman, CEO of TYRX, Inc. “In addition to the AIGIS Retrospective Registry, we have begun the process of recruiting approximately 20 clinical sites for the AIGIS Prospective Registry, which will follow AIGIS patients for 12 months and compare the incidence of infection to published historical and case-matched controls of cardiac rhythm management device (CRMD) recipients. TYRX is committed to better understanding how the AIGIS envelope can help the greatest number of patients.”
