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Think protection, Think TYRX™

82% reduction of pocket infections with TYRX™ envelope in presence of haematoma1

TYRX™ Absorbable Antibacterial Envelope may benefit patients at risk of CIED procedure-related haematoma1

Newly published WRAP-IT Study data in a Heart Rhythm Journal manuscript shows the TYRX™ Absorbable Antibacterial Envelope can reduce risk of major cardiac implantable electronic device (CIED) infection by 82% in patients with a procedure-related haematoma.

Through all follow-up, the risk of major infection was significantly higher among control patients with haematoma versus those without. The manuscript also shows the risk of major infection was significantly lower in the envelope population.

 

Circular image of Tyrx held by hands with purple gloves.
Tyrx Haematoma graph

The overall haematoma rate was 2.22% at 30 days, and there was no difference between treatment groups (p = 0.39).

All major CIED infections in patients with haematoma were pocket infections, none were due to bacteremia or endocarditis. 

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Better outcomes With the Tyrx™ envelope

See how TYRX™, a medical device indicated for CIED stabilization, can significantly lower incidence of major CIED infections compared to standard-of-care infection prevention strategies alone.2

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The impact of CIED infections

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Brief Statement:

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 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 substances rifampicin and minocycline, which have 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, rifampicin, or absorbable sutures; in patients with systemic lupus erythematosus (SLE) because minocycline has been reported to aggravate this condition; in contaminated or infected wounds.

References

1

Tarakji KG, Korantzopoulos P, Philippon F, et al. Infectious consequences of hematoma from cardiac implantable electronic device procedures and the role of the antibiotic envelope: A WRAP-IT Trial Analysis. Heart Rhythm. Published online July 16, 2021.

2

Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. May 2019;380(20):1895-1905.