Abstract
Since the first use of the Guglielmi detachable coil system for cerebral aneurysm embolization in 1990, various endovascular methods have been developed to treat large numbers of aneurysms. The main strategic and technical modifications introduced to date include balloon-assisted coil embolization, stent-assisted coil embolization, flow diverters, and flow disrupters. The development and introduction of such devices have been so persistent and rapid that new devices are being approved worldwide even before the earlier ones become available in some countries. However, even if some patient populations may possibly benefit from earlier introduction of new devices, the approval authorities should balance the available evidence of the safety and effectiveness of novel devices. This review aims to provide an overview of the recent innovations in endovascular treatment of cerebral aneurysms and a brief review of market access policies and regulations for importing high-risk medical devices, such as those used for endovascular aneurysm management, which correspond to class III devices, as defined by the U.S. Food and Drug Administration. We focus on the current situation in Korea and compare it with that in other Asian countries, such as China and Japan.