May 18. 2009 - TYRX Inc. announced the initial, interim clinical results from its AIGISRX Antibacterial Envelope Retrospective Registry during Heart Rhythm 2009 in Boston last week.
AIGIS is an antibacterial mesh envelope developed to deliver antimicrobial 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 multicentered, 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 clinical sites have been enrolled in the study with a 98 percent success rate of CRMD implantation, with the 2 percent of failures not being AIGIS related, the company said. 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. Two studies report the median time to CRMD infection. One stated median time was 14 days and a second reported a median time to infection of 52 days.
“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,” said Dan Lerner, M.D., TYRX’s chief medical officer. “Of the three generator pocket infections reported to date, two occurred in patients who had prior explants for infection within the past six 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 three additional clinical sites, TYRX will collect data on over 500 AIGIS patients, representing more than 15 percent 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.”
For more information: www.TYRX.com