Method for preclinical pathology evaluation and analysis of cardiovascular implantable electronic device implant sites

Jessen, Staci L.; O'Brien, Mackenzie; Lancon, Trevor W.; Smith, Harrison R.; Suarez, Leslie L.; Wilcox, Matthew; Miller, M. F.; Weeks, Brad R.; Clubb, Fred J.

doi:10.1016/j.carpath.2018.05.002

Cited by 3 publications

(1 citation statement)

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“…Directing the flow of saline/formalin by ligating appropriate vasculature will determine which areas are cleared of residual blood and then subsequently fixed. In pacemaker/defibrillator lead studies, for example, ligation of the aortic branches will direct fixative into the inferior vena cava and allow rinsing of residual postexplant blood from the lead implant sites in the myocardium (Jessen et al 2018). This ensures adequate tissue fixation while the regions of interest remain intact and undisturbed during explantation and postexplant handling.…”

Section: Considerations For Preclinical Study Developmentmentioning

confidence: 99%

Introduction to Currently Applied Device Pathology

et al. 2019

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Pathologic evaluation is crucial to the study of medical devices and integral to the Food and Drug Administration and other regulatory entities' assessment of device safety and efficacy. While pathologic analysis is tailored to the type of device, it generally involves at a minimum gross and microscopic evaluation of the medical device and associated tissues. Due to the complex nature of some implanted devices and specific questions posed by sponsors, pathologic evaluation inherently presents many challenges in accurately assessing medical device safety and efficacy. This laboratory's experience in numerous collaborative projects involving veterinary pathologists, biomedical engineers, physicians, and other scientists has led to a set of interrelated assessments to determine pathologic end points as a means to address these challenges and achieve study outcomes. Thorough device evaluation is often accomplished by utilizing traditional paraffin histology, plastic embedding and microground sections, and advanced imaging modalities. Combining these advanced techniques provides an integrative, comprehensive approach to medical device pathology and enhances medical device safety and efficacy assessment.

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Section: Considerations For Preclinical Study Developmentmentioning

confidence: 99%