Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept.
Cardiovasc Revasc Med
; 37: 112-117, 2022 04.
Article
em En
| MEDLINE
| ID: mdl-34607786
ABSTRACT
Effective treatment strategies and medical devices continue to be needed in Japan and the United States of America (US) to mitigate the growing burden of cardiovascular disease and coronary heart disease. Unfortunately, there can be a delay in gaining cardiovascular device approval in Japan after a device has already been approved and is in use in the US. The Harmonization by Doing (HBD) program; however, can eliminate this delay and reduce the cost of completing a clinical trial in Japan. The HBD proof-of-concept study, COAST, resulted in approval of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown simultaneously in Japan and the US on the same day. Subsequently, the Diamondback 360® Coronary OAS Classic Crown also received approval in Japan. The COAST study provides further evidence that global clinical trials via HBD for medical devices are practical and advantageous.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doença da Artéria Coronariana
/
Aterectomia Coronária
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Calcificação Vascular
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Intervenção Coronária Percutânea
Limite:
Humans
País/Região como assunto:
America do norte
/
Asia
Idioma:
En
Revista:
Cardiovasc Revasc Med
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2022
Tipo de documento:
Article