TY - JOUR
T1 - Japan-USA Orbital Atherectomy for Calcific Coronary Lesions
T2 - COAST Study, Harmonization by Doing Proof-of-Concept
AU - Martinsen, Brad J.
AU - Kumar, Katherine
AU - Saito, Shigeru
AU - Sharma, Samin K.
AU - Ikeno, Fumiaki
AU - Fearnot, Neal E.
AU - Shlofmitz, Richard A.
AU - Thatcher, Robert
AU - Krucoff, Mitchell W.
N1 - Publisher Copyright:
© 2021
PY - 2022/4
Y1 - 2022/4
N2 - 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.
AB - 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.
KW - Coronary artery calcification
KW - Coronary artery disease
KW - Global clinical trial
KW - Harmonization by Doing
KW - Orbital atherectomy
KW - Percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=85116206615&partnerID=8YFLogxK
U2 - 10.1016/j.carrev.2021.08.021
DO - 10.1016/j.carrev.2021.08.021
M3 - Article
C2 - 34607786
AN - SCOPUS:85116206615
SN - 1553-8389
VL - 37
SP - 112
EP - 117
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
ER -