This will play a video - Hands holding Medtronic ICD inside TYRX envelope

Significant Reduction Of CIED Infections

TYRX™ WRAP-IT Study — the largest randomised, 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

  • Randomised 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.  

Click to read the manuscript

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.

TYRX™ Cardiac Absorbable Antibacterial Envelope

*

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu

The envelope is intended to hold the following CIED securely to create a stable environment when implanted in the body at the following locations: Implantable Pulse Generator (IPG), Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Devices (CRT-P and CRT-D); implant locations are pectoral, abdominal, or flank (lateral to the body midline and superior to the gluteal) regions.

The envelope contains the ancillary medicinal substance ansamycin, which has been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the device.

The envelope is contraindicated for use in patients with allergy or history of allergy to tetracyclines, ansamycin, or absorbable sutures; in patients with systemic lupus erythematosus (SLE) because minocycline has been reported to aggravate this condition; in contaminated or infected wounds.