最新テクノロジー（デバイス）の福音とリスク

目次・コンテンツ

Over View
・・・東邦大学医療センター大橋病院循環器内科　中村正人
1．Introduction and Prospect of HBD Activities
1）Introduction
・・・独立行政法人医薬品医療機器総合機構医療機器審査第二部　岩元　真
2）Prospect of HBD Activities and Expectations for Future ～ Academia's View
・・・湘南鎌倉総合病院循環器科　齋藤　滋
3）Prospect of HBD Activities and Expectations for Future ～ Industry's View
・・・セント・ジュード・メディカル株式会社　　　　　　　
・・・一般社団法人 日本医療機器産業連合会 国際政策戦略委員会　HBD分科会　関口和亮
4）Prospect of HBD Activities and Expectations for Future ～Regulator’s View
・・・ Mansfield Fellow（From FDA Center for Devices and Radiological Health）　Kenneth J. Cavanaugh Jr.
2．BRS
1）Evidences Reviewed in the Approval of BRS ～ Absorb Ⅲ
・・・Abbott Vascular, Chief Medical Officer　Charles Simonton
2）Evidences Reviewed in the Approval of BRS ～ Absorb Japan
・・・帝京大学医学部附属病院循環器内科　上妻　謙
3）Evidences Reviewed in the Approval of BRS ～ FDA Panel Recommendations
・・・ Mansfield Fellow（From FDA Center for Devices and Radiological Health）　Kenneth J. Cavanaugh Jr.
4）Remaining Concerns ～ USA’s Concern
・・・ Mansfield Fellow（From FDA Center for Devices and Radiological Health）　Kenneth J. Cavanaugh Jr.
5）Remaining Concerns ～ PMDA’s Concern
・・・独立行政法人医薬品医療機器総合機構医療機器審査第三部　大内貴司
6）Expansion of Indication for a Newly Approved Device
・・・Abbott Vascular, Chief Medical Officer　Charles Simonton
3．FFRCT
1）Appropriate PCI ～ Opinion from Academia
・・・福岡山王病院循環器内科　横井宏佳
2）Appropriate PCI ～ Regulatory Concern
・・・独立行政法人医薬品医療機器総合機構医療機器審査第三部　方　眞美
3）Evidences Reviewed in the Approval of CT FFR ～ Clinical Trial
・・・Aarhus University Hospital Skejby, Department Cardiology　Bjarne Nørgaard
4）What is the Best Way to Introduce CT-FFR in Daily Practice? ～ Regulatory Opinion
・・・厚生労働省保険局医療課　國光文乃
5）What is the Best Way to Introduce CT-FFR in Daily Practice?～ Opinion from Industry
・・・ハートフロー・ジャパン合同会社　川畑佳樹
4．Prevention from Bleeding
1）Key Lecture：Significance of Bleeding Complication
・・・東北大学加齢医学研究所加齢制御研究部門基礎加齢研究分野　堀内久徳
2）New Type of DES Proposed for Preventing Bleeding ～ Proposal from Industry (1)
・・・Biosensors International, Chief Medical Officer　Hans-Peter Stoll
3）New Type of DES Proposed for Preventing Bleeding ～Proposal from Industry(2)
・・・Boston Scientific, Senior Vice President, Chief Medical Officer, Interventional Cardiology　Craig A. Thompson
4）Subset of the Patients Who Are at High Risk of Bleeding ～Opinion from Industry
・・・Biosensors International, Chief Medical Officer　Hans-Peter Stoll
5）Subset of the Patients Who Are at High Risk of Bleeding ～Opinion from Academia
・・・Duke University Medical Center, Professor of Medicine / Cardiology
・・・Duke Clinical Research Institute, Director, Cardiovascular Devices Unit　Mitchell W. Krucoff
6）Subset of the Patients Who Are at High Risk of Bleeding ～Opinion from PMDA
・・・独立行政法人医薬品医療機器総合機構医療機器審査第三部　白井裕子


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