WRAP-IT Study Results
- 40% reduction of major CIED infections*1
- 61% reduction of pocket infections1
- Safety endpoint met, no increased risk of complications with use of TYRX through 12 months1
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The TYRX™ Absorbable Antibacterial Envelope is designed for use with cardiac implantable electronic devices (CIEDs), including implantable cardioverter defibrillators (ICDs) and pacemakers.Download sell sheet
CIED stabilization, reduced infection<sup>1-9</sup>
An estimated 1.5 million patients worldwide receive a CIED every year.10 Infections are a serious CIED procedure-related complication, associated with significant morbidity, mortality, and cost:
of CIED patients have been shown to develop infection<sup>1,11</sup>
at 1 year<sup>12</sup>
The largest randomized, controlled, global CIED trial<sup>1</sup>
Note: Considerations for patient selection include use of TYRX to hold a CIED securely in order to provide a stable environment.
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.
Studies were conducted on nonabsorbable envelopes.
Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. May 16, 2019;380(20):1895-1905.
Huntingdon Life Sciences Study TR-2011-054.
Osoro M, Lorson W, Hirsh JB, Mahlow WJ. Use of an antimicrobial pouch/envelope in the treatment of Twiddler’s syndrome. Pacing Clin Electrophysiol. February 2018;41(2):136-142.§
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. February 2011;34(2):133-142.§
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.§
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.
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.§
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.§
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.§
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.
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.
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.
Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med. November 14, 2011;171(20):1821-1828.
Medicare Provider Analysis and Review (MEDPAR) File, FY 2012. Data on file with Medtronic plc.
2012 Premier Healthcare Database. Data on file with Medtronic plc.
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.
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. August 2016;9(8).
Greenspon AJ, Eby EL, Petrilla AA, Sohail MR. Treatment patterns, costs, and mortality among Medicare beneficiaries with CIED infection. Pacing Clin Electrophysiol. May 2018;41(5):495-503.
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.
Huntingdon Life Sciences Study TR-2013-001.
Sinclair Labs Study D13599.
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.