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Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan

Circulation journal : official journal of the Japanese Circulation Society, 2024-09, Article CJ-24-0474

2024

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Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data

Circulation Journal, 2022/11/25, Vol.86(12), pp.1990-1997

2022

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Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

Circulation Journal, 2020/08/25, Vol.84(9), pp.1568-1574

2020

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First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan　― Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent

Circulation Journal, 2018/05/25, Vol.82(6), pp.1487-1490

2018

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Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective　― Reply

Circulation Journal, 2018/11/24, Vol.82(12), pp.3111

2018

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Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

Journal of artificial organs, 2021-03, Vol.24 (1), p.90-101

2021

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Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI)　― A Joint USA-Japanese Perspective

Circulation Journal, 2018/08/24, Vol.82(9), pp.2233-2239

2018

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Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold

Internal Medicine, 2021/01/15, Vol.60(2), pp.161-166

2021

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Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　― Harmonization By Doing for Children

Circulation Journal, 2020/04/24, Vol.84(5), pp.786-791

2020

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Regulatory approval review of transcatheter mitral valve repair – Difference in the indication between the USA and Japan

Journal of cardiology, 2019-07, Vol.74 (1), p.13-18

2019

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Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint

Heart and vessels, 2021-02, Vol.36 (2), p.155-162

2021

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Valve Academic Research Consortium Consensus Report

Journal of the American College of Cardiology, 2011-08, Vol.58 (7), p.777-777

2011

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Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC)

Journal of the American College of Cardiology, 2015-03, Vol.65 (9), p.931-941

2015

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Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective

Cardiovascular revascularization medicine, 2022-04, Vol.37, p.118-119

2022

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Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

Circulation Journal, 2020/07/17, pp.CJ-20-0133

2020

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Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold

Internal Medicine, 2020, pp.4286-19

2020

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Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data

Circulation Journal, 2022/09/01, pp.CJ-22-0185

2022

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Valve Academic Research Consortium Consensus Report: The Pharmaceutical and Medical Devices Agency Perspective

Journal of the American College of Cardiology, 2011-08, Vol.58 (7), p.777-777

2011

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Pediatric Medical Devices　― Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan

Circulation Reports, 2021/03/10, Vol.3(3), pp.153-160

2021

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Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective　― Reply

Circulation Journal, 2018, pp.CJ-18-1066

2018

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Hard-to-heal wound treatment medical devices: clinical trial protocol in Japan

Journal of wound care, 2021-08, Vol.30 (8), p.666-676

2021

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Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct

Cardiovascular revascularization medicine, 2023-07, Vol.52, p.67-74

2023

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Pediatric Medical Devices　― Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan

Circulation Reports, 2021/01/26, pp.CR-20-0136

2021

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Activities of Harmonization By Doing; including development of pediatric medical devices

Transactions of Japanese Society for Medical and Biological Engineering, 2018, Vol.Annual56(Abstract), pp.S10-1-S10-1

2018

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Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan

Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data

Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan　― Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent

Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective　― Reply

Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI)　― A Joint USA-Japanese Perspective

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　― Harmonization By Doing for Children

Regulatory approval review of transcatheter mitral valve repair – Difference in the indication between the USA and Japan

Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint

Valve Academic Research Consortium Consensus Report

Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease

Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC)

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective

Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold

Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data

Valve Academic Research Consortium Consensus Report: The Pharmaceutical and Medical Devices Agency Perspective

Pediatric Medical Devices　― Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan

Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective　― Reply

Hard-to-heal wound treatment medical devices: clinical trial protocol in Japan

Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct

Pediatric Medical Devices　― Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan

Activities of Harmonization By Doing; including development of pediatric medical devices

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