Guidelines and Post-market Surveillance of Flow Diverter for Intracranial Aneurysms

抄録

Flow diverter (FD) is stent-like fine-mesh device for the treatment of intracranial aneurysms, and endovascular therapy with FD has been developed for aneurysms difficult to be cured by standard treatment, and is already widely introduced in other countries. Japanese Society of Neuroendovascular Therapy (JSNET) submitted FD to the government committee as a priority device for the Japanese market in 2011. And, Pipeline Flex (Medtronic Neurovascular, Irvine, CA, USA) was approved in 2015, based on the result of an approving study in Japan and published data of pipeline for uncoilable or failed aneurysms (PUFS) study. At Pipeline Flex approval, three related medical societies, Japan Neurosurgical Society, Japan Stroke Society, and JSNET, established a clinical guideline, including clinical indication of FD, institute criteria, and operator criteria. Furthermore, these societies prepared to operate a clinical database of all cases where FD was used and post-market surveillance will be reported using this database. These activities may work for development of FD in Japan with support of the Ministry of Health, Labour and Welfare, Japan and Pharmaceuticals, and Medical Devices Agency.