Identifying Patients at High Risk for Infection
A patient’s procedures, medications, and characteristics significantly increase the risk of cardiac implantable electronic device (CIED)-related infection.1-7 The TYRX™ Absorbable Antibacterial Envelope significantly reduces the incidence of CIED infection for patients with these risk factors.6,8,10,11
As shown below, the device type and procedure type influence the risk level to the patient.
ODDS RATIO FOR DEVELOPING A CIED INFECTION
As shown below, the device type and procedure type influence the risk level to the patient.
Patient Risk Stratification
1
Klug D et al. Circulation. 2007;116(12):1349-1355.
2
Margey R et al. Europace. 2010;12(1):64-70.
3
Sohail MR et al. Clin Infect Dis. 2007;45(2):166-173.
4
Lekkerkerker JC et al. Heart. 2009;95(9):715-720.
5
Romeyer-Bouchard et al. Eur Heart J. 2010;31(2):203-210.
6
Bloom H et al. Pacing Clin Electrophysiol. 2006;29(2):142-145.
7
Herce et al. Europace. 2013;15(1):66-70.
8
Kolek MJ et al. J Cardio Electrophysiol. 2015;26(10):1111-1116.
9
Shariff N et al. J Cardio Electrophysiol. 2015;26(10):783-789.
10
Henrikson CA et al. JACC EP.2017;3(10):1158-1167.
11
Mittal S et al. Heart Rhythm. 2014;11(4):595-601.
TYRX™ Cardiac Absorbable Antibacterial Envelope
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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.