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Tyrx Absorbable Antibacterial Envelope

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The impact of CIED infection

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

>3x MORTALITY RISK at 1 year4   tyrx 

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21,760€ - 70,329€ ASSOCIATED TO CIED INFECTION5-8  



21,760€-70,329€ ASSOCIATED TO CIED INFECTION5-8    

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23-30 DAYS AVERAGE HOSPITAL LENGTH OF STAY TO TREAT INFECTIONS9-11

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The solution... 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

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Demonstrated CIED STABILISATION17, 18

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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

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Want to learn more about how you can move closer to zero risk of CIED infection with the TYRX™ envelope?12, 16, 20

TYRX OVERVIEW
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The Evidence... TYRX™ cardiac antibacterial envelope for CIED infection reduction

THE WRAP-IT STUDY: THE LARGEST RANDOMISED, CONTROLLED, GLOBAL CIED TRIAL1

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TYRX Cardiac Antibacterial Envelope to Reduce CIED Infections1

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THE WRAP-IT STUDY SUMMARY

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THE WRAP-IT STUDY MANUSCRIPT

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TYRX™ CARDIAC ABSORBABLE ANTIBACTERIAL ENVELOPE. DEMONSTRATED CIED STABILISATION, REDUCED INFECTION1, 17, 18

tyrx technology overview

Why do infections continue to be a problem?

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the true cost of infection  

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THE WRAP-IT STUDY ACC LATE BREAKER

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INTERNATIONAL CONSENSUS DOCUMENT RECOMMENDS TYRX™ CARDIAC ENVELOPE TO REDUCE CIED INFECTION21

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EHRA CONSENSUS DOCUMENT SUMMARY

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ehra consensus manuscript

ehra consensus paper

THE LATEST STRATEGIES

TO REDUCE CARDICAC DEVICE INFECTIONS

TYRX™ ECONOMIC VALUE PROPOSITION SUMMARY

tyrx value proposition summary

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VALUE BASED HEALTHCARE OUTCOMES PROGRAMME

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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.

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 substances rifampicin and minocycline, which have 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, rifampicin, or absorbable sutures; in patients with systemic lupus erythematosus (SLE) because minocycline has been reported to aggravate this condition; in contaminated or infected wounds.