Pathological Safety Assessment in Preclinical Neurothrombectomy Studies

Toxicol Pathol. 2019 Apr;47(3):264-279. doi: 10.1177/0192623319826066. Epub 2019 Mar 4.

Abstract

The design, production, and preclinical testing of neurothrombectomy devices is in a burgeoning phase as the demand escalates for safe and reliable treatment options following neurovascular stroke. Currently, there is a paucity of published data describing the development of iatrogenic vascular lesions occurring secondary to neurothrombectomy procedures. In an effort to test new devices, demonstrate device safety, satisfy regulatory requirements, and develop an understanding of the potential for associated vascular pathology, investigators are establishing appropriate methodology in suitable animal models. Significant challenges exist in identifying a single animal species that can be consistently utilized in all phases of device development. These aforementioned challenges are underscored by the intricacies of neurovascular pathology, thrombovascular interactions, and vascular responses to injury.

Keywords: endovascular injury; histopathology; neurothrombectomy; porcine; preclinical.

Publication types

  • Review

MeSH terms

  • Animals
  • Cerebral Arteries* / injuries
  • Equipment Design / methods
  • Equipment Design / standards
  • Equipment Safety / standards*
  • Medical Device Legislation
  • Stroke / surgery*
  • Thrombectomy / instrumentation*
  • United States
  • United States Food and Drug Administration
  • Vascular Access Devices / adverse effects
  • Vascular Access Devices / standards*