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Preclinical evaluation of a third-generation absorbable antibacterial envelope.

Charles J Love1, Ibrahim Hanna2, George Thomas3

  • 1Department of Medicine, Johns Hopkins Medicine, Baltimore, Maryland.

Heart Rhythm
|January 24, 2023
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Summary

The new third-generation TYRX antibacterial envelope matches the second-generation's infection prevention and drug elution. It also significantly reduces device migration, meeting all performance criteria for cardiac device stabilization.

Keywords:
Cardiac implantable electronic deviceInfectionPreclinical evaluationsStabilizationTYRX

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Area of Science:

  • Biomedical Engineering
  • Infectious Diseases
  • Materials Science

Background:

  • The TYRX (Medtronic) absorbable antibacterial envelope stabilizes implantable cardiac devices and reduces infection.
  • A third-generation envelope was developed with a redesigned mesh and enhanced form factor to reduce surface roughness, while maintaining identical polymer coating and antibiotic concentrations as the second-generation envelope.

Purpose of the Study:

  • To compare the drug elution, bacterial challenge efficacy, stabilization, and absorption of second-generation versus third-generation TYRX envelopes.

Main Methods:

  • Antibiotic elution assessed in vitro and in vivo.
  • Bacterial challenge efficacy evaluated in rabbits (n=40) with device insertions.
  • Stabilization (migration, rotation) assessed in sheep (n=5) with device implants.

Main Results:

  • Third-generation envelopes demonstrated equivalent antibiotic elution to second-generation envelopes, remaining above minimal inhibitory concentration (MIC) in vivo for 7 days.
  • Both envelope generations significantly reduced bacterial infections compared to no envelope (P <.05).
  • Third-generation envelopes showed significantly less device migration (5.5 mm vs 9.9 mm, P <.05) but similar rotation (P = .79) compared to second-generation envelopes.

Conclusions:

  • The third-generation TYRX envelope exhibits equivalent preclinical performance to the second-generation envelope.
  • It meets all acceptance criteria for antibiotic elution, infection reduction, device stabilization, and absorption.
  • This suggests the third-generation envelope is a safe and effective option for preventing infections associated with implantable cardiac devices.