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2018 ; 20
(1
): 46-56
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Development of New Endovascular Devices for Aneurysm Treatment
#MMPMID29402066
Jia ZY
; Shi HB
; Miyachi S
; Hwang SM
; Sheen JJ
; Song YS
; Kim JG
; Lee DH
; Suh DC
J Stroke
2018[Jan]; 20
(1
): 46-56
PMID29402066
show ga
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.