TYRX Neuro Absorbable Antibacterial Envelope
Helping Reduce Infections in Implantable Neurostimulators
Overview
The TYRX™ Neuro Absorbable Antibacterial Envelope is a fully absorbable antibacterial envelope for implantable neurostimulator (INS) devices, including vagal nerve stimulators, spinal cord neuromodulators, deep brain stimulators, or sacral nerve stimulators. The surgical mesh envelope contains two powerful antibiotics — minocycline and rifampin. It is designed to stabilize the device and help reduce the risk of infection and infection-related costs. The TYRX absorbable polymer coating contains antimicrobial agents minocycline and rifampin in the amount of 102 µg/cm2 for both medium and large envelope sizes.
INDICATIONS
The TYRX Neuro Absorbable Antibacterial Envelope is intended to securely hold an INS in place in order to provide a stable environment when implanted in the body. The TYRX Neuro 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.1 This device is only intended to be used in conjunction with vagal nerve stimulators, spinal cord neuromodulators, deep brain stimulators, or sacral nerve stimulators.
PRODUCT DETAILS: TYRX NEURO ABSORBABLE ANTIBACTERIAL ENVELOPE
Proven stabilization in holding devices securely in place to provide a stable environment when implanted in the body.2,3
- Reduces the chance of device migration, erosion, or Twiddler Syndrome.2,4
- In vivo models demonstrate that the porous mesh of the TYRX Antibacterial Envelope enables dense fibrous connective tissue ingrowth immediately after implant, which firmly anchors the device in 7-14 days.
Synergistic combination of minocycline and rifampin shown to reduce infection associated with other medical devices in multiple, randomized controlled trials.5-8
- Minocycline and rifampin elute locally into the tissue pocket enabling minimum inhibitory concentration (MIC) of the antibiotic drug levels in the tissue to be reached within 2 hours of implantation, which are maintained for a minimum of 7 days: locally eluted, adjunctive antibacterial protection.2-9
- Non-systemic dose: TYRX Envelopes contain <5% of the recommended oral daily doses, 7.6 mg of minocycline & 11.9 mg of rifampin.9
After absorption, no foreign body nidus for potential infection.
- Fully absorbs into the body in approximately 9 weeks.2
- Requires no adjustment to standard surgical techniques during replacement or revision procedures.
Novel, large-pore mesh knitted from absorbable multifilaments coated with an absorbable polyarylate polymer, which breaks down into naturally occurring components generally regarded as safe (GRAS). The composition of the mesh filament is similar to absorbable suture.9
TYRX NEURO ENVELOPE DISPERSES ANTIBIOTICS AND BREAKS DOWN OVER TIME
The TYRX Neuro Envelope is made of large-pore knit filaments similar to a 5.0 suture. It’s coated in an amino acid tyrosine-based polymer, which disperses the antibiotics and breaks down over time, primarily via hydrolysis. The envelope is fully absorbed into the body in approximately 9 weeks.
TYRX Medium Neuro Envelope is 2.5” (6.3 cm) x 2.7” (6.9 cm), and the TYRX Large Neuro Envelope is 3.0” (7.6 cm) x 3.35” (8.5 cm).
The TYRX Neuro Envelope after implantation elutes antibiotics.
Four weeks post-op, the TYRX Neuro Envelope dissolves into fragments.
Approximately nine weeks post-op, the TYRX Neuro Envelope fully absorbs.
Manufacturing the TYRX Absorbable Antibacterial Envelope - (03:51)
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EFFECTIVE ANTIBIOTIC COMBINATION
Each TYRX Neuro Envelope contains the synergistic combination of minocycline and rifampin.
Minocycline is a bacteriostatic antimicrobial that inhibits protein synthesis and has been shown effective against gram-positive bacteria such as S aureus and gram-negative bacteria such as E coli, E aerogenes, H influenza, and A baumannii. *
The minocycline dose per TYRX Neuro Envelope is 5.1 mg (medium) and 7.6 mg (large).
Rifampin is a bactericidal antimicrobial that interferes with DNA-dependent RNA polymerase activity.10 It has been shown to be effective against gram-positive bacteria such as S aureus (including MRSA) and S epidermidis and gram-negative bacteria such as H influenza.
The rifampin dose per TYRX Neuro Envelope is 8.0 mg (medium) and 11.9 mg (large).
MANUALS AND TECHNICAL GUIDES
Instructions for Use
Find this technical manual in the product labeling supplied with each device or call Medtronic at 800-961-9055.
*
Medtronic Infection Control technology — based on inventions by Joachim Kohn, PhD, surrounding unique biodegradable polymer technology (i.e., tyrosine-derived polyarylates) — has received a world-wide license from Rutgers, The State University of New Jersey, which covers a broad range of absorbable materials and drug delivery technology.
1
Huntingdon Life Sciences Study TR-2011-043, TR-2011-044, TR-2011-045, TR-2011-047, TR-2011-056.
2
Huntingdon Life Sciences Study TR-2011-054.
3
Ferrando JM et al. Early Imaging of Integration Response to Polypropylene Mesh in Abdominal Wall by Environmental Scanning Electron Microscopy: Comparison of Two Placement Techniques and Correlation with Tensiometric Studies. World J Surg. 2001;25:291-366.
4
Osoro M et al. Pacing Clin Electrophysiol. 2018;41: 136-142.
5
Hanna H et al. J Clin Oncol. 2004;22(15):3163-3171.
6
Leon C et al. Intensive Care Med. 2004;30(10):1891-1899.
7
Chatzinikolaou I et al. Am J Med. 2003;115(5):352-357.
8
Raad I et al. Ann Intern Med. 1997;128(4):267-274.
9
TYRX Neuro Absorbable Antibacterial Instructions for Use.
10
The Sanford Guide to Antimicrobial Therapy. Web Edition. 2015: Antimicrobial Therapy Inc.; Hyde Park, VT.
Tyrx Neuro Absorbable Antibacterial Envelope Brief Statement
The TYRX Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body. The Neuro 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 a pulse generator. The Neuro Antibacterial Envelope is NOT indicated for use in patients who have an allergy or history of allergies to tetracyclines, Rifampin, or absorbable sutures. The Neuro Antibacterial Envelope is also NOT indicated for use in patients with contaminated or infected wounds, or Systemic Lupus Erythematosus (SLE). This device is intended to be used in conjunction with vagus nerve stimulators or deep brain stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region. 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 Neuro Antibacterial Envelope and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity.
PATENTS
All Medtronic TYRX Infection Control Products are protected under one or more of these patents:
U.S. Nos. 8315700, 8591531.
European (FR)(IE)(DE)(GB)(ES)(IT)(BE)(NL) patent no. 1484080B1.
European (FR)(DE)(GB)(IE)(IT)(BE)(ES)(NL) patent no. EP1028774B1.
European (GB)(FR)(IE)(DE)(CH)(NL) patent no. 1908490B1.
Medtronic TYRX™ owns or licenses an additional 70 patent applications worldwide covering proprietary products targeting cardiovascular, cosmetic surgical applications and other pharmaceutical applications.