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

Brad J. Martinsen, Katherine Kumar, Shigeru Saito, Samin K. Sharma, Fumiaki Ikeno, Neal E. Fearnot, Richard A. Shlofmitz, Robert Thatcher, Mitchell W. Krucoff

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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.

Original languageEnglish
Pages (from-to)112-117
Number of pages6
JournalCardiovascular Revascularization Medicine
Volume37
DOIs
StatePublished - Apr 2022

Keywords

  • Coronary artery calcification
  • Coronary artery disease
  • Global clinical trial
  • Harmonization by Doing
  • Orbital atherectomy
  • Percutaneous coronary intervention

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