TYRX announced that an interim analysis found its AIGISRx Antibacterial Envelope prevented major infections among high-risk patients undergoing cardiovascular implantable electronic device replacement procedures.
The TYRX-funded study is examining the device infection and mechanical complication rates among 1,000 patients at high risk for CIED infection. In one arm of the study, a group of patients underwent CIED replacement with cardiac resynchronization therapy and the antibacterial envelope, and a second group of patients underwent the procedure without the envelope.
An interim analysis of the three months following the procedure showed patients who were implanted with the antibacterial envelope had zero major infections, compared with six infections in the control group, an infection rate of 1.2 percent. There was no significant difference in the rate of CIED mechanical complications between the two groups, according to the news release.