Zerelda E. Garrigos
1,2*
John N. Catanzaro
3
Daniel Deegan
4*The final, formatted version of the article will be published soon.
ORIGINAL RESEARCH article
Front. Drug Deliv.
Sec. Cardiovascular Drug Delivery
Volume 4 - 2024 |
doi: 10.3389/fddev.2024.1441956
Preclinical Evaluation of a Novel Antibiotic-Eluting BioEnvelope for CIED Infection Prevention
Provisionally accepted- 1 Division of Infectious Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, United States
- 2 Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, Minnesota, United States
- 3 East Carolina Heart Institute at ECU Health Medical Center, Greenville, Illinois, United States
- 4 Elutia Inc., Silver Spring, Maryland, United States
- 5 Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas, United States
The risk of infection remains a significant concern with cardiovascular implantable electronic devices, necessitating the development of new strategies. This study explores the efficacy of a novel antibiotic-eluting biologic envelope designed to mitigate infection risk through localized antibiotic delivery while preserving the regenerative properties of biological matrix. Antibiotics, rifampin and minocycline, are released through polymer discs, ensuring extended drug release. Utilizing an established model of infection in a New Zealand White rabbit, the study assessed performance against gram-positive bacterial strains, including common pathogens such as S. aureus and S. epidermidis associated with CIED infections, and gram-negative bacterial strains. Results demonstrated strong antibacterial activity, achieving complete eradication of bacterial colonies and greater than 6-log reductions in colonization for all strains. Pharmacokinetic analysis revealed sustained local antibiotic concentrations at the implantation site for up to 14 days, with minimal systemic exposure, demonstrating the advantages of localized drug delivery. Health outcomes in the antibiotic bioenvelope group were significantly improved, with no signs of infection or abnormal body temperatures, in contrast to the control group. Macroscopic examinations post-necropsy confirmed the absence of infection at the implantation sites of animals receiving the antibiotic bioenvelope. The combination of localized antibiotic delivery in a regenerative matrix positions the antibiotic bioenvelope as a promising solution for preventing CIED-related infections.
Keywords: Cardiac Implantable Device Envelope, CIED, antibacterial envelope, Biologic Envelope, Biomaterial-Supported Drug Delivery, Rifampin, Minocycline
Received: 31 May 2024; Accepted: 26 Aug 2024.
Copyright: © 2024 Garrigos, Catanzaro, Deegan, Zhang and Sohail. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Zerelda E. Garrigos, Division of Infectious Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, MS 39216, Mississippi, United States
Daniel Deegan, Elutia Inc., Silver Spring, Maryland, United States
Ji Zhang, Elutia Inc., Silver Spring, Maryland, United States
M. R. Sohail, Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, 77030, Texas, United States
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