Infection Control with TYRX Absorbable Antibacterial Envelope

TYRX™ Absorbable Antibacterial Envelope is the only fully absorbable antibacterial device that is FDA-cleared for CIED and INS stabilization and to help prevent infection.
 

TYRX Antibacterial Envelope is:

  • Supported by 6 clinical studies proving its efficacy to help prevent CIED infection
  • Specifically designed to aid in the stabilization of CIED and INS placement


How It Works:

  • Minocycline and Rifampin elute locally into the tissue pocket, enabling MIC levels to be reached within 2 hours of implantation and maintain for a minimum of 7 days: locally delivered, adjunctive antibacterial protection8
  • Mesh substrate absorbs into the body in ~9 weeks; no change necessary in surgical technique during replacement and revision
    procedures1
  • After absorption, no foreign body nidus for potential infection
     

Four Reasons Physicians Should Consider Using the
TYRX Absorbable Antibacterial Envelope – "TIME"

  1. Reduces the chance of Twiddler Syndrome9
  2. Helps prevent Infection2
  3. Reduces the chance of device Migration2
  4. Reduces the chance of device Erosion2


Stabilize CIED Placement. Help Prevent CIED Infection.

 
 

Bacterial infection is one of the most common causes of CIED complications … and is on the rise

In a retrospective analysis examining CIED implants between 1993-2008, investigators found a 210%  increase in the incidence of infection with CIED implantation over the course of this 15-year time period. 

This increased rate of infection was likely due to:1

  • Older patients receiving devices
  • More patient comorbidities
  • Longer procedures
  • Mix of CIED devices is changing
  • Number of pulse generator replacements and upgrades are increasing
  • Revisions
  • More resistant S aureus and coagulase (-) Staphylococcus species (e.g., S epidermidis)

 

This webpage is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.

References

Greenspon AJ, Patel JD, Lau E, et al. 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008J Am Coll Cardiol. 2011;58(10):1001-1006
Huntingdon Life Sciences Study TR-2011-054.
Hanna H, Benjamin R, et al. Long-Term Silicone Central Venous Catheters Impregnated with Minocycline and Rifampin Decrease Rate of Catheter-Related Bloodstream Infection in Cancer Patients: A Randomized Clinical Trial. J Clin Oncol. 2004;22(15):3163-3171.
Leon C, Ruiz-Santana S, Rello J et al. Benefits of minocycline and rifampin-impregnated central venous catheters. A prospective, randomized, double-blind, controlled, mulitcenter trial. Intensive Care Med. 2004;30(10):1891-1899.
Zabramski JM, Whiting D, Darouiche RO, et al. Efficacy of antimicrobial-impregnated external ventricular drain catheters: a prospective, randmoized, controlled trial. J Neurosurg. 2003;98(4):725-730.
Chatzinikolaou, I, Finkel, K, Hanna, H et al. Antibiotic-coated hemodialysis catheters for the prevention of vascular catheter-related infections: a prospective, randomized study. Am J Med. 2003; 115: 352–357

Raad, I, Darouiche, R, Dupuis, J et al. Central venous catheters coated with minocycline and rifampin for the prevention of catheter-related colonization and bloodstream infections. A randomized double-blind trial. Ann Intern Med. 1997; 128: 267–274
TYRX Absorbable Antibacterial Envelope Instructions for Use.
Hirsh J. Clinical Case Report: Recurrent Twiddler's SyndromeEP Lab Digest, July 2012;12(7)
10 Shariff N, Eby E, Adelstein E, et al. Health and Economic Outcomes Associated with Use of an Antimicrobial Envelope as a Standard of Care for Cardiac Implantable Electronic Device Implantation. J Cardiovasc Electrophysiol. 2015;26(7): 783-9.
11 Henrikson CA, Citadel & Centurion Studies. Poster presentation at European Heart Rhythm Association (EHRA), Cardiostim 2014.
12 Gould PA, Gula LJ, Champagne J, et al. Outcome of advisory implantable cardioverter-defibrillator replacement: one-year follow-up. Heart Rhythm. 2008;5(12): 1675-1681
13 Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Increased long-term mortality in patients with cardiovascular implantable electronic device infections. Pacing Clin Electrophysiol. 2015;38(2): 231-239

Last updated: 
24 Feb 2016