Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Martinsen, BJ; Kumar, K; Saito, S; Sharma, SK; Ikeno, F; Fearnot, NE; Shlofmitz, RA; Thatcher, R; Krucoff, MW

Published Date

  • April 2022

Published In

Volume / Issue

  • 37 /

Start / End Page

  • 112 - 117

PubMed ID

  • 34607786

Electronic International Standard Serial Number (EISSN)

  • 1878-0938

Digital Object Identifier (DOI)

  • 10.1016/j.carrev.2021.08.021


  • eng

Conference Location

  • United States