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.
PurposeTransduodenal ampullectomy (TDA) has been reported in a limited number of cases and in a small number of case series. The aim of this study was to analyze perioperative and long-term oncological outcomes of patients with ampullary tumors who underwent TDA in a single large-volume center.MethodsThrough a retrospective review of data from 2004 to 2016, we identified 26 patients who underwent TDA at Asan Medical Center.ResultsEleven of 26 patients underwent TDA for T1 and carcinoma in situ (high-grade dysplasia) cancer; these patients are still alive without recurrence. A major in-hospital complication (3.8%) occurred in 1 case, but there was no case of 90-day mortality. In addition, none of the patients was diagnosed as having newly developed diabetes mellitus after TDA. No significant differences were found between open and laparoscopic-TDA in terms of operation time, painkiller use, and hospital stay.ConclusionTDA is a feasible and effective surgical procedure for the treatment of selected patients with ampullary tumors. It is an alternative treatment option in cases of ampullary tumors not amenable to endoscopic papillectomy or pancreaticoduodenectomy.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.