Study on how to apply a simulation technique to evaluate a development of new medical devices and a possibility of their market approval

2014 Fiscal Year Final Research Report

• Project/Area Number: 25560247
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Medical engineering assessment
• Research Institution: National Institute of Health Sciences
• Principal Investigator: NAKAOKA Ryusuke 国立医薬品食品衛生研究所, 医療機器部, 室長 (20291114)
• Co-Investigator(Kenkyū-buntansha): UEMATSU Miyuki 国立医薬品食品衛生研究所, 医療機器部, 主任研究官 (10434813) ; UMEZU Mitsuo 早稲田大学, 理工学術院, 教授 (90132927)
• Project Period (FY): 2013-04-01 – 2015-03-31
• Keywords: 非臨床評価 / 新医療機器 / 大動脈瘤 / ステントグラフト / 拍動循環シミュレータ

Outline of Final Research Achievements

A stent graft is a medical device for an endovascular treatment to prevent rupture of the aortic aneurysm. A fenestration type of the graft is utilized for preserving blood flow of arch and trifurcation vessels with the aneurysm. Medical doctors could predict the angle of graft rotation within an aorta under the pulsatile situation based on over 100 cases of clinical experience. Therefore, they know how to deploy a stent graft appropriately. However, it is difficult to feed others good tips on the stent graft deployment. The purpose of this study is to provide evidences with a mock system to promote awareness in clinical practice. We have developed a test method under pulsatile situation for evaluating aortic stent grafts.

Free Research Field

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