Issue link: https://beckershealthcare.uberflip.com/i/1235187
ONE MORE REASON TO USE THE TYRX ™ ENVELOPE TO HELP PREVENT CIED* INFECTION TYRX ™ WRAP-IT Study adds compelling clinical data** 1 to an existing large body of literature 2-7 demonstrating SIGNIFICANT reduction in CIED Infection with the TYRX Envelope *Cardiac Implantable Electronic Device 1. Tarakji KG et al. N Engl J Med. 2019;380:1895-1905. 2. Bloom HL et al. Pacing Clin Electrophysiol. 2011;34(2):133-142. 3. Henrikson CA et al. JACC EP. 2017;3(10):1158-1167. 4. Kolek MJ et al. Pacing Clin Electrophysiol. 2013;36(3):354-361. 5. Kolek MJ et al. J Cardio Electrophysiol. 2015;26(10):1111-1116. 6. Mittal S et al. Heart Rhythm. 2014;11(4):595-601. 7. Shariff N et al. J Cardio Electrophysiol. 2015;26(10):783-789. 8. Huntingdon Life Sciences Study TR-2011-054. 9. Osoro M et al. Pacing Clin Electrophysiol. 2018;41:136-142. 10. Huntingdon Life Sciences Study TR-2013-001. 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. **75% of initial major CIED infections in the study were pocket infections 1 THE TYRX TM ABSORBABLE ANTIBACTERIAL ENVELOPE MEETS THE CLINICAL CHALLENGES OF CIED COMPLICATIONS ■ Demonstrated CIED stabilization 8,9 ■ Tyrosine-based polymer elutes minocycline and rifampin into the tissue pocket 10 to help prevent CIED-related infections 1-7 ■ MIC reached within 2 hours, maintained for a minimum of 7 days 10 ■ Mesh fully absorbs in ~9 weeks; no foreign body nidus 10 Copyright © 2019, Medtronic, Inc. UC20204322EN medtronic.com/envelope | medtronic.com/wrap-it | 800.848.9300