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TYRX Presents Early Clinical Results from AIGISRX(TM) Antibacterial Envelope Retrospective Registry
Date:5/14/2009

MONMOUTH, N.J., May 14 /PRNewswire/ -- TYRX, Inc., a leader in the commercialization of implantable medical-pharmaceutical devices announced today at the 30th Annual Scientific Sessions of the Heart Rhythm Society the initial, interim clinical results from its AIGISRX(TM) Antibacterial Envelope Retrospective Registry.

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.(1) report the median time to CRMD infection as 14 days, and Klug et al.(2) reported a median time to infection of 52 days, the preliminary infections rates in the ARR are as follows:

    All Patients w/ greater than or equal to 1 Follow-up

                               PM                           ICD/CRT
                                       infection                     infection
     Implant Type  implants infecti
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SOURCE  TYRX, Inc.
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