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Absorbable antibacterial envelopes

TYRX™ absorbable antibacterial envelope

<p>The TYRX™ absorbable antibacterial envelope is used with cardiac implantable electronic devices, including implantable cardioverter defibrillators.</p>

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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 infections

1-4%

of CIED patients
have shown to develop infections2-3

>3X

mortality risk at 1 year4

23-30 days

average time in hospital9-11

21K€ - 70K€

associated to CIED infections5-8

Clinical evidence

Unmatched clinical evidence

  • WRAP-IT: approximately 7,000 patient, largest randomized, controlled, global CIED trial1
    • 61% reduction in pocket infections
    • 40% reduction in major infections
    • 82% reduction in major infections in presence of hematoma
  • Over 1,500,000 patients protected 2 globally and approximately 13,000 patients studied,1,3-14 notably approximately 1,800 patients in the REINFORCE study14
    • Prospective, real-world trial inclusive of lower risk patients
    • Sustained infection reduction at five years
    • Benefit seen across all patient risk categories
Explore the results of the largest, randomized, controlled, global CIED trial.

International consensus document recommends TYRX™ envelope to reduce CIED infection22

Read more (open in new window)

TYRX™ envelope is recommended for the WRAP-IT study population and for patients with high risk factors22

   
CIED infection risk
 
CRT-D Increased§ Increased§ Highest
ICD Low Increased§
Pacemaker/
CRT‑P		 Low Increased§
  • Initial procedure • Replacement
• Revision
• Upgrade		 • Dialysis
• Immunosuppressive agents
• Recent infection

KOL interviews

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

Find out more on the REINFORCE study

Watch the interview with Dr. Ziacchi

Pocket stabilization

Interview with Professor Duncker

Deep dive into the Blister Score

Watch the interview with Dr. Edd Maclean

Learn more about the Pocket Health study

Watch the interview with Prof. Jay Wright

Medtronic Academy

Educational resources on Medtronic Academy

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

Visit Medtronic Academy (open in new window)

Ordering information

Item number CMRM6133 CMRM6122 NMRM6133 NMRM6122
Therapy Cardiac Neuro
Quantity Single unit Single unit Single unit Single unit
Size Large Medium Large Medium
Dimensions 2.9” (7.4 cm) × 3.3 in (8.5 cm) 2.5” (6.3 cm) × 2.7” (6.9 cm) 2.9” (7.3 cm) × 3.3” (8.5 cm) 2.5” (6.3 cm) × 2.7” (6.9 cm)

† 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.

‡ Included patients for CIED revision, generator replacement, upgrade, or de novo CRT-D.

§ Included in the WRAP-IT Study patient cohort.

  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. Sayadi JJ, Rodrigues AJ, Patel NA, Ayer A, Henderson JM. A retrospective cohort study of implantable pulse generator surgical site infections after deep brain stimulation surgery with an antibacterial envelope. Neuromodulation. 2023;26(2):435–442. doi: 10.1016/j.neurom.2022.02.227.
  14. Ziacchi M, Biffi M, Iacopino S, et al. REducing INFectiOns thRough Cardiac device Envelope: insight from real world data. The REINFORCE project. Europace. 2023;25(11):euad244. doi: 10.1093/europace/euad224.
  15. Blomstrom-Lundqvist C, Traykov V, Erba PA, et al. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Europace. 2020;22:515–549. doi: 10.1093/europace/euz246.
  16. Baddour LM, Garrigos ZE, Sohail MR, et al. Update on cardiovascular implantable electronic device infections and their prevention, diagnosis, and management: a scientific statement from the American Heart Association. Circulation. 2023;149(2):e201–e216. doi: 10.1161/CIR.0000000000001187.
  17. Huntingdon Life Sciences Study TR-2013-001.
  18. Sinclair Labs Study D13599.
  19. Virmani R, Philippon F, Mittal S, et al. Effects of envelopes on cardiac implantable electronic device pocket healing: A head-to-head pre-clinical evaluation. Heart Rhythm. 2024;21(8)1325–1333. doi: 10.1016/j.hrthm.2024.02.054.
  20. Philippon F, Ladich E, Virmani R, et al. Absorbable antibacterial envelope promotes development of a healthy CIED pocket. Poster presented at: 2024 HRS conference; May 16–19, 2024; Boston, MA.