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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The impact of CIED infections

 

Demonstrated CIED stabilization and reduced infection1–9

$48K–83K

average hospital
cost to treat an infection7,12–16

$5K–36K

average margin
loss to treat an infection7,12–19

$2K

average patient 
out-of-pocket costs12

An estimated 1.5 million patients worldwide receive a CIED every year.20 Infections are a serious CIED procedure-related complication, associated with significant morbidity, mortality, and cost.

1–4%

of CIED patients have been shown to develop infection1,21

> 3X

mortality risk  at 1 year12

9–18 days

average time in hospital12,13

Clinical evidence

The largest randomized, controlled, global CIED trial1

  • 6,983 patients at increased risk for pocket infection‡
  • 25 countries
  • 181 centers
  • 776 implanters

International consensus document recommends TYRX™ envelope to reduce CIED infection22

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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

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. Huntingdon Life Sciences study TR-2011-054.
  3. Osoro M, Lorson W, Hirsh JB, Mahlow WJ. Use of an antimicrobial pouch/envelope in the treatment of Twiddler’s syndrome. Pacing Clin Electrophysiol. 2018;41(2):136–142.
  4. Bloom HL, Constantin L, Dan D, et al. Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope. Pacing Clin Electrophysiol. 2011;34(2):133–142.
  5. 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. 2014;11(4):595–601.
  6. 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. 2015;26(10):1111–1116.
  7. 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):783–789.
  8. 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. 2017;3(10):1158–1167.
  9. 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. 2013;36(3):354–361.
  10. Huntingdon Life Sciences study TR-2013–001.
  11. Sinclair Labs study D13599.

  1. Wilkoff BL, et al. Impact of CIED Infection: A Clinical and Economic Analysis of the Wrap-It Study. Presentation Su3088 at AHA Scientific Sessions 2019; Philadelphia, PA.
  2. Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med. 2011;171(20):1821–1828.
  3. Medicare Provider Analysis and Review (MEDPAR) File, FY 2012. Data on file with Medtronic plc.
  4. 2012 Premier Healthcare Database. Data on file with Medtronic plc.
  5. Lopatto, et al. Antibacterial Envelope is Associated with Medical Cost Savings in Patients at High Risk for Cardiovascular Implantable Electronic Device Infection. Presented at ACC 2017; Washington, DC.
  6. Sohail MR, Eby EL, Ryan MP, Gunnarsson C, Wright LA, Greenspon AJ. Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection: Evidence From a Large US Payer Database 1-Year Post Implantation. Circ Arrhythm Electrophysiol. 2016;9(8).
  7. Greenspon AJ, Eby EL, Petrilla AA, Sohail MR. Treatment patterns, costs, and mortality among Medicare beneficiaries with CIED infection. Pacing Clin Electrophysiol. 2018;41(5):495–503.
  8. Eby EL, Bengtson LGS, Johnson MP, Burton ML, Hinnenthal J. Economic impact of cardiac implantable electronic device infections: Cost analysis at one year in a large United States health insurer. J Med Econ. Published online April 7, 2020.
  9. 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.
  10. Tarakji KG, Ellis CR, Defaye P, Kennergren C. Cardiac Implantable Electronic Device Infection in Patients at Risk. Arrhythm Electrophysiol Rev. 2016;5(1):65–71.
  11. Blomström-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. Published online November 8, 2019.