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

Shin Iwamoto; Moe Ohashi; Haruki Shirato; Mami Ho; Misti Malone; Kenneth Cavanaugh

doi:10.1016/j.carrev.2021.08.020

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

Cardiovasc Revasc Med. 2022 Apr:37:118-119. doi: 10.1016/j.carrev.2021.08.020. Epub 2021 Sep 1.

Authors

Shin Iwamoto¹, Moe Ohashi², Haruki Shirato³, Mami Ho⁴, Misti Malone⁵, Kenneth Cavanaugh⁶

Affiliations

¹ Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; U.S. & Japan Medical Device Harmonization by Doing (HBD) Group, USA. Electronic address: [email protected].
² Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; U.S. & Japan Medical Device Harmonization by Doing (HBD) Group, USA. Electronic address: [email protected].
³ Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; U.S. & Japan Medical Device Harmonization by Doing (HBD) Group, USA. Electronic address: [email protected].
⁴ Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; U.S. & Japan Medical Device Harmonization by Doing (HBD) Group, USA. Electronic address: [email protected].
⁵ U.S. Food and Drug Administration, Silver Spring, MD, USA; U.S. & Japan Medical Device Harmonization by Doing (HBD) Group, USA. Electronic address: [email protected].
⁶ U.S. Food and Drug Administration, Silver Spring, MD, USA; U.S. & Japan Medical Device Harmonization by Doing (HBD) Group, USA. Electronic address: [email protected].

PMID: 34483075
DOI: 10.1016/j.carrev.2021.08.020

Abstract

Regulatory approval processes for medical devices in Japan and the United States of America (US) often require similar clinical trials to establish safety and effectiveness. The Harmonization by Doing (HBD) program provides a collaborative environment for communication between regulators, academics and industry, facilitating the design and conduct of US/Japanese clinical trials supporting approval in both countries.

Keywords: Coronary artery calcification; Coronary artery disease; Global clinical trial; Global medical device development; Harmonization by Doing; Orbital atherectomy; Percutaneous coronary intervention.

Published by Elsevier Inc.

Publication types

Letter
Comment

MeSH terms

Atherectomy
Atherectomy, Coronary* / adverse effects
Coronary Angiography
Coronary Artery Disease* / diagnostic imaging
Coronary Artery Disease* / surgery
Humans
Japan
Percutaneous Coronary Intervention* / adverse effects
Treatment Outcome
United States
Vascular Calcification* / diagnostic imaging
Vascular Calcification* / therapy