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THE WRAP-IT STUDY: THE LARGEST RANDOMISED, CONTROLLED, GLOBAL CIED TRIAL1
INTERNATIONAL CONSENSUS DOCUMENT RECOMMENDS TYRX™ CARDIAC ENVELOPE TO REDUCE CIED INFECTION21
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.
Tarakji KG, et al. Arrhythm Electrophysiol Rev. 2016;5:65-71.
Tarakji KG, et al. N Engl J Med. 2019;380:1895-1905.
Wilkoff BL. AHA Scientific Sessions 2019; Su3088.
Sohail MR, et al. Circ Arrhythm Electrophysiol. 2016;9:e003929.
Clémenty N et al. Europace. 2018;20(12):1974-1980
Ludwig S et al. J Comp Eff Res. 2018;7(5):483-492.
Ahsan SY et al. Europace. 2014; (16):1482–1489.
Burnhope E et al. J Med Econ. 2019 Feb 12:1-7 epub.
Ahsan SY, et al. Europace. 2014;16:1482-1489.
Egea M, et al. Poster Presentation EHRA Congress 2018.
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.
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.
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.
Huntingdon Life Sciences Study TR-2011-054.
Osoro M, et al. Pacing Clin Electrophysiol. 2018;41:136-142.
Ferrando JM, et al. World J Surg. 2001;25:840-847.
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.
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.
Boriani G et al., Value in Health 2021, doi: https://doi.org/10.1016/j.jval.2020.12.021
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.