TYRX™ Neuro absorbable antibacterial envelope
The TYRX™ neuro absorbable antibacterial envelope is designed to provide device stabilization when implanted. The envelope also contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation.*
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Overview
TYRX™ neuro absorbable antibacterial envelope
The TYRX™ Neuro Absorbable Antibacterial Envelope shares technology with the TYRX™ Absorbable Antibacterial Envelope for cardiac implantable electronic devices (CIEDs). The largest randomized controlled, global trial with CIEDs showed a reduced rate of infections among high-risk patients with CIEDs.1
PRODUCT DETAILS
Creates stablity
- Creates a stable environment when implanted in the body
- Absorbable mesh is fully absorbed by the body in approximately 9 weeks2
Elutes antibiotics
locally
- Localized delivery of minocycline and rifampin enables the TYRX™ envelope to achieve MIC† level within two hours and to maintain it for a minimum of seven days3
- A combination of minocycline and rifampin has been used in urology since 20014
Antibiotic combination helps reduce infections
- SNM device-related infection rates typically are ~2-5%5,6‡
- Minocycline and rifampin have reduced infections by 70 to 100% in cardiac devices7-11§
Offers protection
- MIC† levels still achieved seven days after implantation, providing extended protection
- TYRX™ technology has been used in more than 475,000 patients in over 55 countries
Disclaimer
The evidence for reduction of device infection with the TYRX™ neuro absorbable antibacterial envelope is based on data with cardiac implantable electronic devices as demonstrated via a randomized controlled clinical trial1 and multiple clinical studies.12 To date, there has been no published clinical studies on TYRX™ neuro with implantable neurostimulators.
*
TYRX™ neuro absorbable antibacterial envelope instructions for use.
†
Minimum inhibitory concentration
‡
Infection rates vary by study and clinical practice
§
Infection data based on cardiovascular procedures against pathogens that commonly inhabit a wound bed in subcutaneous tissue pockets
1
Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial envelope to prevent cardiac implantable device infection. N Engl J Med. 2019;380(20):1895-1905.
2
Huntingdon Life Sciences Study TR-2011-054.
3
Huntingdon Life Sciences Study TR-2013-001.
4
Carson CC, 3rd. Efficacy of antibiotic impregnation of inflatable penile prostheses in decreasing infection in original implants. The Journal of Urology. 2004;171(4):1611-1614.
5
Noblett K, Benson K, Kreder K. Detailed analysis of adverse events and surgical interventions in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients. Neurourol. Urodynam. 2017; 36(4):1136-1139.
6
Bielefeldt K. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration. World J Gastrointest Pharmacol Ther. 2016;7(2):294-305.
7
Henrikson CA, Sohail MR, Acosta H, et al. Antibacterial envelope Is associated with low infection rates after implantable cardioverter-defibrillator and cardiac resynchronization therapy device replacement: Results of the Citadel and Centurion Studies. JACC Clin Electrophysiol. 2017;3(10):1158-1167.
8
Mittal S, Shaw RE, Michel K et al. Cardiac implantable electronic device infections: incidence, risk factors, and the effect of the AigisRX antibacterial envelope. Heart Rhythm. 2014;11(4):595-601.
9
Kolek MJ, Dresen WF, Wells QS, Ellis CR. Use of an antibacterial envelope is associated with reduced cardiac implantable electronic device infections in high-risk patients. Pacing Clin Electrophysiol. 2013;36:354-361.
10
Kolek MJ, Patel NJ, Clair WK et al. Efficacy of a bio-absorbable antibacterial envelope to prevent cardiac implantable electronic device infections in high-risk subjects. J Cardiovasc Electrophysiol. 2015;26(10):1111-1116.
11
Shariff N, Eby E, Adelstein E et al. Health and economic outcomes associated with use of an antimicrobial envelope as a standard of care for cardiac implantable electronic device implantation. J Cardiovasc Electrophysiol. 2015;26(7):783-789.
12
Kumar A, Doshi R, Shariff M. Role of antibiotic envelopes in preventing cardiac implantable electronic device infection: A meta-analysis of 14 859 procedures. J Arrhythm. 36(1):176-179.