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

Area of Science:

• Cardiovascular Medicine
• Medical Device Regulation
• Clinical Trials

Background:

• Cardiovascular disease (CVD) and coronary heart disease (CHD) pose a significant health burden in Japan and the United States (US).
• Delays in regulatory approval for cardiovascular devices in Japan, compared to the US, hinder patient access to innovative treatments.
• The Harmonization by Doing (HBD) program aims to expedite the approval process for medical devices through international collaboration.

Purpose of the Study:

• To evaluate the feasibility and advantages of the HBD program for simultaneous medical device approval in Japan and the US.
• To assess the impact of the HBD program on reducing clinical trial timelines and costs.
• To provide evidence supporting the adoption of HBD for future medical device regulatory submissions.

Main Methods:

• The COAST study served as a proof-of-concept for the HBD program.
• Global clinical trial data was utilized to support simultaneous regulatory submissions.
• The Diamondback 360® Coronary Orbital Atherectomy System Micro Crown was the primary device evaluated.

Main Results:

• Simultaneous approval of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown was achieved in Japan and the US on the same day.
• Subsequent approval of the Diamondback 360® Coronary OAS Classic Crown in Japan further validated the HBD approach.
• The HBD program demonstrated practical advantages in expediting regulatory processes.

Conclusions:

• The HBD program is a practical and advantageous approach for global medical device clinical trials.
• Implementing HBD can significantly reduce the time lag for device approval between Japan and the US.
• The COAST study provides strong evidence for the effectiveness of HBD in accelerating patient access to novel cardiovascular technologies.