Your browser is out of date

With an updated browser, you will have a better Medtronic website experience. Update my browser now.

×

Skip to main content

Helping Reduce Infections in Pacing Systems and CIEDs

The TYRX™ Absorbable Antibacterial Envelope is the only fully absorbable antibacterial envelope available for cardiac implantable electronic devices (CIEDs), including ICDs and pacemakers. 

The impact of CIED infection

An estimated 1.5 million patients worldwide receive a CIED every year.(23) Infections are a serious CIED procedure-related complication, associated with significant morbidity, mortality, and cost:


1-4% of CIED patients
have shown to develop infections2, 3


23-30 days
average time in hospital9-11


>3X
mortality risk at 1 year4


21,760€ - 70,329€
associated to CIED infections5-8

The TYRX technology

Moving closer to zero risk of CIED infection with the TYRX™ cardiac absorbable antibacterial envelope12-16, 20

  • 40% reduction of major infections1
  • 61% reduction of pocket infections1 
  • Demonstrated CIED stabilisation17,18
  • Mesh fully absorbs in ~9 weeks17,19
  • Significant reduction of CIED infections1
  • No increased risk of complications with the use of TYRX1
  • Polymer-controlled elution, sustained for 7 days17
Learn more (opens new window)

Clinical Evidence

The Wrap-it study

The largest randomised, controlled, global CIED trial1

  • 40% reduction of major infections
  • 61% reduction of pocket infections
  • No increased complication risk or procedure time
TYRX Infection Control
Learn more (opens new window)
Download the summary (opens new window)
Download the manuscipt (opens new window)

TYRXTM Cardiac Absorbable Antibacterial Envelope 
demonstrated CIED stabilisation, reduced infection1,17,18

TYRX technology overview

Why do infections continue to be a problem?

 

Download overview (opens new window)

The true cost of infection

Discover how adoption of TYRX in high-risk patients benefits providers, patients, and the healthcare system.
 

Learn more (opens new window)

The Wrap-It study ACC late breaker

Read more about the World-Wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) to reduce CIED Infection.

Download presentation (opens new window)

International consensus document recommends TYRXTM cardiac envelope to reduce CIED infection21 

EHRA consensus document summary

The EHRA International consensus document recommends TYRX™ Cardiac Envelope to reduce CIED infection. Read about it here:

Download the summary (opens new window)

EHRA consensus manuscript

The EHRA International consensus document recommends TYRX™ Cardiac Envelope to reduce CIED infection. Read about it here:

Download the EHRA consensus paper (opens new window)

KOL interviews

Watch our KOL Interview series to learn more about new TYRX clinical data and what it could mean for your patients.

New video
Pocket stabilization:
Interview with Professor Duncker

Blister score:
Interview with Dr Maclean
 

Pocket health:
Interview with Professor Wright
 

Economic Evidence

Value-based healthcare outcomes programme

Discover more about the clinical & economic impact of CIED and demonstrated cost savings in High-Risk patients.

Download the document (opens new window)

Need help to create a business case to implement TYRX in your facility?

Request more information about the TYRX cardiac Absorbable Antibacterial Envelope.

Request now (opens new window)
Medtronic Academy

Educational resources on
Medtronic Academy

Find additional feature information along with a variety of educational resources and tools.

Visit Medtronic Academy (opens new window)

References

1

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

2

Tarakji KG, et al. Arrhythm Electrophysiol Rev. 2016;5:65-71.

3

Tarakji KG, et al. N Engl J Med. 2019;380:1895-1905.

4

Wilkoff BL. AHA Scientific Sessions 2019; Su3088.

5

Sohail MR, et al. Circ Arrhythm Electrophysiol. 2016;9:e003929.

6

Clémenty N et al. Europace. 2018;20(12):1974-1980

7

Ludwig S et al. J Comp Eff Res. 2018;7(5):483-492.

8

Ahsan SY et al. Europace. 2014; (16):1482–1489.

9

Burnhope E et al. J Med Econ. 2019 Feb 12:1-7 epub.

10

Ahsan SY, et al. Europace. 2014;16:1482-1489.

11

Egea M, et al. Poster Presentation EHRA Congress 2018.

12

Tarakji KG, Ellis CR, Defaye P. Kennergren C. Cardiac Implantable Electronic Device Infection in Patients at Risk, Arrhythm Electrophysiol Rev. May 2016; 5 (1): 65-71. Bloom HL, Constantin L, Dan D, et al.

13

Mittal S, Shaw RE, Michel K, et al. Cardiac implantable electronic device infections: incidence risk factors, and the effect of the AigisRx antibacterial envelope. Heart Rhythm. April 2014;11(4):595-601.

14

Kolek MJ, Patel NJ, Clair WK, et al. Efficacy of a Bio-Absorbable Antibacterial Envelope to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Subjects. J Cardiovasc Electrophysiol. October 2015;26(10):1111-1116.

15

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. July 2015;26(7):783-789.

16

Kolek MJ, Dresen WF, Wells QS, Ellis CR. Use of an antibacterial envelope is associated with reduced cardiac implantable electronic device infections in high-risk patients. Pacing Clin Electrophysiol. March 2013;36(3):354-361.

17

Huntingdon Life Sciences Study TR-2011-054.

18

Osoro M, et al. Pacing Clin Electrophysiol. 2018;41:136-142.

19

Ferrando JM, et al. World J Surg. 2001;25:840-847.

20

Henrikson CA, Sohail MR, Acosta H, et al. Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: results of the Citadel and Centurion Studies. JACC Clin Electrophysiol. October 2017;3(10):1158-1167.

21

Blomstrom-Lundqvist C, et al. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device. Europace 2019;1–35.

22

Boriani G et al., Value in Health 2021, doi: https://doi.org/10.1016/j.jval.2020.12.021(opens new window)

23

Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009 — a World Society of Arrhythmia’s project. Pacing Clin Electrophysiol. 2011; 34: 1013-1027.

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.