Issue link: https://beckershealthcare.uberflip.com/i/483154
The TYRX Absorbable Antibac terial Envelope is NOT indicated for use in patients who have an allergy or histor y of allergies to tetrac yclines, rifampin, or resorbable sutures. The TYRX Absorbable Antibac terial Envelope is also NOT indicated for use in patients with contaminated orinfec ted wounds; or systemic lupus er y thematosus (SLE). The use of this produc t in patients with compromised hepatic and renal func tion, or in the presence of hepatotoxic or renal toxic medications, should be considered carefully, because rifampin and minoc ycline can cause additional stress on the hepatic and renal systems. Patients who receive the TYRX Absorbable Antibac terial Envelope and who are also taking methox y urane should be monitored carefully for signs of renal toxicity. T YRX™ ABSORBABLE ANTIBACTERIAL ENVELOPE Stabilize CIED placement May help prevent CIED infection UC201504005 Designed to hold CIEDs (such as pacemakers and implantable cardioverter-de brillators) securely in place to provide a stable environment when implanted in the body. 1, 2 • Reduces chance of device migration, erosion, or Twiddler Syndrome. 1,2 Synergistic combination of minocycline and rifampin shown to reduce infection in other medical devices in multiple, randomized controlled trials. 3-7 • Elutes locally into the tissue for a minimum of 7 days: site-speci c, adjunctive antibacterial protection. 8 Bioabsorbable mesh fully absorbs into the body in ~9 weeks. 1 • Requires no adjustment to standard surgical techniques during replacement or revision procedures. • After absorption, no foreign body nidus for infection. Multiple studies support clinical e cacy. • Patients at high risk for CIED infection implanted with the TYRX Antibacterial Envelope had 70% to 90% fewer infections compared to patients without it. *, 9 -12 Signi cantly reduces costs of infection in CIED implants. • Your facility can potentially reduce costs by as much as $50,000 for every 100 TYRX Envelopes used with your high-risk CIED patients. 11-14 *Studies performed utilizing the TYRX™ Antibacterial Envelope. For more information visit T YR X.com & HeartDeviceInfection.com. Copyright ©2015. Medtronic TYRX, Inc. 1. Huntingdon Life Sciences Study TR-2011-054. 2. Hirsh J. EP Lab Digest, July 2012; 12(7). 3. Leon C et al. Intensive Care Med. 2004;30(10):1891-1899. 4. Zabramski JM et al. J Neurosurg. 2003;98(4):725-730. 5. Chatzinikolaou I et al. Am J Med. 2003;115(5):352-357. 6. Raad I et al. Ann Intern Med. 1997;128(4):267-274. 7. Hanna H et al. J Clin Oncol. 2004;22(15):3163-31712. 8. TYRX Absorbable Antibacterial Envelope Instructions for Use. 9. Bloom H et al. Pacing Clin Electrophysiol. 2011; 34(2):133-142. 10. Henrikson CA, Citadel & Centurion Studies. Poster presentation at European Heart Rhythm Association (EHRA), Cardiostim 2014. 11. Kolek MJ et al. Pacing Clin Electrophysiol. 2013;36(3):354-361. 12. Mittal S et al. Heart Rhythm. 2014; 11:595-601. 13. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services Inpatient Prospective payment System (IPPS) Final Rule FY13. 14. Data on le, 090714-1.