1. Huntingdon Life Sciences Study TR-2011-054. 2. Osoro M et al. Pacing Clin Electrophysiol. 2018;41:136-142. 3. Bloom HL et al. Pacing Clin Electrophysiol.
2011;34(2):133-142. 4. Henrikson CA et al. JACC EP. 2017;3(10):1158-1167. 5. Kolek MJ et al. Pacing Clin Electrophysiol. 2013;36(3):354-361. 6. Kolek MJ et al.
J Cardio Electrophysiol. 2015;26(10):1111-1116. 7. Mittal S et al. Heart Rhythm. 2014;11(4):595-601. 8. Shariff N et al. J Cardio Electrophysiol. 2015;26(10):783-789.
9. Tarakji KG et al. N Engl J Med. 2019;380:1895-1905.
40%
61%
MOVING
CLOSER TO
ZERO RISK
OF CIED
*
INFECTION
WITH THE TYRX™ ABSORBABLE
ANTIBACTERIAL ENVELOPE
■
Demonstrated CIED stabilization
1-2
■
70% -100% pocket infection
reduction in initial, real-world studies
3-8
■
61% pocket infection reduction
in WRAP-IT randomized, controlled
CIED study**
9
reduction of
major CIED
Infections**
9
reduction
of pocket
Infections**
9
The TYRX
TM
Envelope
BRIEF STATEMENT The TYRX™ Absorbable Antibacterial Envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to provide a stable
environment when implanted in the body. The TYRX Absorbable Antibacterial Envelope contains the antimicrobial agents minocycline and rifampin, which have been
shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. The TYRX Absorbable Antibacterial
Envelope is NOT indicated for use in patients who have an allergy or history of allergies to tetracyclines, rifampin, or absorbable sutures. The TYRX Absorbable
Antibacterial Envelope is also NOT indicated for use in patients with contaminated or infected wounds, or Systemic Lupus Erythematosus (SLE). The use of this
product in patients with compromised hepatic and renal function, or in the presence of hepatotoxic or renal toxic medications, should be considered carefully,
because minocycline and rifampin can cause additional stress on the hepatic and renal systems. Patients who receive the T YRX Absorbable Antibacterial
Envelope and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity.
To learn more about the WRAP-IT Study, visit Medtronic.com/wrap-it
*Cardiac Implantable Electronic Device
**75% of initial major CIED infections in the study were pocket infections
9
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|
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