IMPACT OF CIED INFECTIONS TYRX Absorbable Antibacterial Envelope

Consequences of Implantable Cardiac Device Infection on Patients and the Healthcare System

Despite efforts to take pacemaker precautions and reduce pacemaker risks, infection after cardiac implantable electronic defibrillators (CIEDs) implantation is a real possibility. When pacemaker infection does occur, the risk to the patient and the costs to the healthcare system are substantial.1-3        

Infections typically cost the facility an average of about €36,7224 and 26-30 bed days to treat one infection. 4-5    


Mortality significantly increased following CIED infections. Studies show a ~50% mortality rate at three years in patients who had a CIED infection.1

CIED Infections Are Costly

Infections typically cost the facility an average of about €36,7224 and 26-30 bed days to treat one infection. 4-5    



The TYRX™ Absorbable Antibacterial Envelope may help reduce infection; studies show a 70% to 100% reduction of infection in high-risk patients. 6-11

Economic Impact of CIED Infection

A clinical and economic analysis (U.S. data) shows the projected savings of utilizing the TYRX Absorbable Antibacterial Envelope per patient.

Mittal S et al. Heart Rhythm. 2014;11(4):595-601.


Henrikson CA et al. JACC EP.2017;3(10):1158-1167.


Sohail MR et al. Arch Intern Med. 2011;171(20):1821-1828.


Ahsan SY et al. Europace 2014;16: 1482-1489


Ludwig S et al, 2017. Incidence and costs of cardiac device infections: retrospective analysis using German health claims data. J. Comp. Eff. Res. 10.2217/cer-2017-0080 (Epub ahead of print)


Bloom HL et al.Pacing Clin Electrophysiol.2011;(2):133-142


Mittal S et al. Heart Rhythm. 2014;11(4):595-601


Kolek MJ et al. J Cardio Electrophysiol. 2015;26(10):1111-1116


Shariff N et al. J Cardio Electrophysiol. 2015;26(7):783-789


Henrikson CA, et al. JACC EP. 2017;3(10):1158-1167


Kolek MJ et al. Pacing Clin Electrophysiol.2013;36(3):354-361

TYRX™ Cardiac Absorbable Antibacterial Envelope


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

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.