Pathological Safety Assessment in Preclinical Neurothrombectomy Studies

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.

Evaluation of using a double helical, closed-cell stent-retriever (Skyflow) for thrombectomy procedures in acute arterial occlusion: A preclinical study and a clinical trial

“…Vessel wall injury, including vessel perforation, artery dissection, endothelial cell damage, secondary intracranial hemorrhage, and vascular stenosis, is a common complication of thrombectomy. 9 , 28 , 29 In this study, the Skyflow device showed excellent flexibility and an appropriate stent size for different vessels to avoid iatrogenic vascular damage. As a result, it achieved good safety with only mild vasospasm on DSA images and no obvious damage to vessel architecture.…”