First Analyses of TYRX's AIGISRx Anti-Bacterial Envelope Retrospective Registry

Sep 21 2009

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."

When comparing the ARR ICD/CRT cohort to a comparable published control, Gould et al, JAMA 2006, ICD Revisions, the crude major infection rate for the AIGISRx cohort is 69% lower (1.88 v. 0.58). The hazard ratio derived by comparing the Gould et al cohort to the ARR ICD/CRT cohort indicates AIGISRx significantly reduced the risk for major CRMD infection by 84% (6.14 v.> Dr. Heather Bloom, co-investigator and poster presenter, noted, "As a VA physician, a significant portion of the patients referred to me for device implantation have multiple risk factors for CRMD infection. I am excited that the AIGISRx retrospective registry data demonstrates extremely low rates of infection in patients with similar, very high risk, profiles. Since infection carries such devastating consequences, the addition of a new tool that is safe, easy to implant and effective represents huge advancement in the CRM field."

"We are delighted these data indicate clinicians are using AIGISRx in the full spectrum of CRMD implant procedures. In particular, it is gratifying to see that AIGISRx 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 AIGISRx Retrospective Registry, we have begun the process of recruiting approximately 20 clinical sites for the AIGISRx Prospective Registry, which will follow AIGISRx 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 AIGISRx envelope can help the greatest number of patients."