To evaluate the safety and effectiveness of TYRX™ Envelope in reducing the risk of CIED (Cardiac Implantable Electronic Device) infection
The TYRX WRAP-IT Study shows a significant reduction of CIED infections with the use of TYRX Envelope. These findings provide strong evidence for use of the TYRX Envelope and the most comprehensive data on CIED infection prevention.
75% of initial major CIED infections in the study were pocket infections.
CIED revision, generator replacement, upgrade or de novo CRT-D
Primary endpoint included CIED infections requiring system extraction or revision, long-term antibiotic therapy with infection recurrence, or death within 12 months of the CIED procedure
Tarakji KG, Mittal S, Kennergren C, et al. The World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) to Reduce Cardiac Implantable Electronic Device Infection. Late-breaking abstract presented at ACC 2019; New Orleans, LA.