Hands holding Medtronic ICD inside TYRX envelope

Significant Reduction Of CIED Infections

TYRX™ WRAP-IT Study — the largest randomized, controlled, global CIED trial
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Study Design

Study Objective

To evaluate the safety and effectiveness of TYRX™ Envelope in reducing the risk of CIED (Cardiac Implantable Electronic Device) infection

Study Design

  • Randomized 1:1 (TYRX vs. no TYRX) clinical trial (RCT) of CIEDs 
  • N = 6,983 patients at an increased risk for pocket infection*
  • Patients received standard-of-care pre-op antibiotic prophylaxis
  • 25 countries
  • 181 centers
  • 776 implanters

Study Results

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.  

40% REDUCTION OF
MAJOR INFECTIONS†1

40% reduction of major CIED infections graph from WRAP-IT Study

61% REDUCTION OF
POCKET INFECTIONS1

61% reduction of CIED pocket infections graph from WRAP-IT Study

75% of initial major CIED infections in the study were pocket infections.

No Increased Complication Risk
or Procedure Time1

  • No increased complication risk with the use of TYRX through 12 months, meeting the safety endpoint.
  • Complications occurred in 6.0% of patients receiving the envelope and in 6.9% of patients in the control group (p < 0.001 for non-inferiority).
  • Procedure success rate with TYRX was 99.7%.
  • No difference in procedure time between the Envelope arm and the Control arm.

*

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 


1

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.