TYRX Absorbable Antibacterial Envelope

Helping Reduce Infections in Pacing Systems and CIEDs

Overview

The TYRX™ Absorbable Antibacterial Envelope is the only fully absorbable antibacterial envelope available for cardiac implantable electronic devices (CIEDs), including ICDs and pacemakers. The absorbable 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.1-5

Infections occur in about 1% to 4% of all CIED implantations,* resulting in a 50% patient mortality rate at 3 years6 and an average treatment cost of $44,000 to $83,000.6-10 The TYRX Envelope has been shown to reduce infection risks by 70% to 100% in high-risk patients.12- 16


INDICATIONS

The TYRX Envelope is intended to hold a pacemaker pulse generator or defibrillator securely in place in order to provide a stable environment when implanted in the body. The powerful antimicrobial agents, minocycline and rifampin, have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the pacemaker or defibrillator.1-5 This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.


PRODUCT DETAILS: TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

The TYRX Envelope is fully absorbable technology uniquely designed for Perfect-PocketTM Protection.

Proven stabilization in holding CIEDs, such as pacemakers and ICDs, securely in place to provide a stable environment when implanted in the body.17-21

  • Reduces the chance of device migration, erosion, or Twiddler Syndrome.17-18

Synergistic combination of minocycline and rifampin shown to reduce infection associated with other medical devices in multiple, randomized controlled trials.1-5

  • 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.17-22
  • Non-systemic dose: TYRX Envelopes contain <5% of the recommended oral daily doses, 7.6 mg of minocycline & 11.9 mg of rifampin.22

The only antibacterial device available for CIED implants that is fully absorbable.

  • Fully absorbs into the body in approximately 9 weeks.17
  • Requires no adjustment to standard surgical techniques during replacement or revision procedure.
  • After absorption, no foreign body nidus for infection.

Novel, large-pore mesh knitted from bioabsorbable multifilaments coated with a bioabsorbable polyarylate polymer that breaks down into naturally occurring components. The composition of the mesh filament is similar to bioabsorbable suture.22

WHY THE NEED FOR ENHANCED PROTECTION FOR YOUR CIED PROCEDURES?

Bacterial infection is one of the most common causes of CIED complications, and it is on the rise.

Over a 15-year period, increase in incidence of infection was more than double the increase in implants (210% vs 96%).7

Change in CIED implants and infections between 1993-2008

TYRX ENVELOPE DISPERSES ANTIOBIOTICS AND BREAKS DOWN OVER TIME

The TYRX 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 Envelope is 2.5” (6.3 cm) x 2.7” (6.9 cm), and the TYRX Large Envelope is 3.0” (7.6 cm) x 3.35” (8.5 cm).

The TYRX Envelope after implantation elutes antibiotics.

The TYRX Envelope after implantation elutes antibiotics.

Four weeks post-op, the TYRX Envelope dissolves into fragments.

Four weeks post-op, the TYRX Envelope dissolves into fragments.

Nine weeks post-op, the TYRX Envelope fully absorbs.

Nine weeks post-op, the TYRX Envelope fully absorbs.

EFFECTIVE ANTIBIOTIC COMBINATION

Each TYRX Envelope contains a 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 Envelope is 5.1 mg (medium) and 7.6 mg (large).

Rifampin is a bactericidal antimicrobial that interferes with DNA-dependent RNA polymerase activity.23 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 Envelope is 8.0 mg (medium) and 11.9 mg (large).


MANUALS AND TECHNICAL GUIDES

Find the Instructions for Use in the product labeling supplied with each device or call Medtronic at 800-961-9055.


*

Infection rate is an aggregation of data; see data on file at Medtronic.

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

Hanna H et al. J Clin Oncol. 2004;22(15):3163-3171.

2

Leon C et al. Intensive Care Med. 2004;30(10):1891-1899.

3

Zambramski JM et al. J Neurosurg. 2003;98(4):725-730.

4

Chatzinikolaou I et al. Am J Med. 2003;115(5):352-357.

5

Raad I et al. Ann Intern Med. 1997;128(4):267-274.

6

Sohail MR et al. PACE. 2015;38(2):231-239.

7

Greenspon A et al. J Am Coll Cardiol. 2011;58(10):1001-1006.

8

2012 Premier Healthcare Database, data on file with Medtronic plc. 

9

2014-15 Medicare 100% Standard Analytic File (SAF), data on file with Medtronic plc.

10

CPI 2016 Detailed Report: CPI1612. Assessed March, 2018.

11

Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services Inpatient Prospective Payment System (IPPS) Final Rule FY13.

12

Bloom HL et al. Pacing Clin Electrophysiol. 2011;34(2):133-142.

13

Mittal S et al. Heart Rhythm. 2014;11(4):595-601.

14

Kolek MJ et al. J Cardio Electrophysiol. 2015;26(10):1111-1116.

15

Shariff N et al. J Cardio Electrophysiol. 2015;26(10):783-789.

16

Henrikson CA et al. JACC EP.2017;3(10):1158-1167.

17

Huntingdon Life Sciences Study TR-2011-054.

18

Hirsh J. EP Lab Digest, July 2012;12(7).

19

Klinge U et al. Influence of Polyglactin-Coating on Functional Morphological Parameters of Polypropylene-Mesh Modifications For Abdominal Wall Repair. Biomaterials. 1999;20:613-623.

20

Pillai CKS et al. Absorbable Polymeric Surgical Sutures: Chemistry, Production, Properties, Biocompatibility and Performance. J Biomater Appl. 2010;25:291-366.

21

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.

22

TYRX Absorbable Antibacterial Instructions for Use.

23

The Sanford Guide to Antimicrobial Therapy. Web Edition. 2015: Antimicrobial Therapy Inc.; Hyde Park, VT.


TYRX Absorbable Antibacterial 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 TYRX Absorbable 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.