Image of two gloved hands holding a Medtronic ICD within a TYRX envelope on a gray background

Significant Reduction Of CIED Infections

TYRX WRAP-IT Study — the largest randomized, controlled, global CIED trial1
Download Summary

Study Design1

Study Objective

To evaluate the safety and effectiveness of TYRX™ Absorbable Antibacterial 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 Absorbable Antibacterial Envelope.

40% REDUCTION OF MAJOR INFECTIONS†1

Major CIED Infection Rate (%)

Graph showing 40% reduction of major infections with TYRX Envelope

61% REDUCTION OF POCKET INFECTIONS1

Major CIED Pocket Infection Rate (%)

Graph showing 61% reduction of pocket infections with TYRX Envelope

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

No Increased Complication Risk or Procedure Time‡1

Complication Rate (%)

Graph showing use of TYRX envelope did not increase complication risk
  • 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.

Procedure- and system-related complications through 12 months.

Reference

1

Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. May 16, 2019;380(20):1895-1905.