Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan.

Abstract

The CorPath GRX system (Corindus) was approved in 2018, enabling the first robotic-assisted percutaneous coronary intervention (PCI) in Japan. The approval was based on the results of clinical studies from other countries conducted with the first-generation CorPath 200 system (Corindus). Considering no proven use of a remote control device for PCI in Japan, confirming the efficacy and safety of the CorPath GRX system in Japanese real-world clinical practice through a use-results survey was deemed necessary. One condition for approval was that necessary measures should be taken to ensure that the product is used by appropriate operators and facilities. These measures included the dissemination of guidelines for proper use developed in conjunction with related academic societies and the implementation of training courses. The survey results confirmed that the CorPath GRX system is effective and safe. However, some characteristics of the implementation procedure differed from those reported in clinical studies from other countries. This review demonstrates that collecting real-world data is useful for understanding product safety and efficacy, and for identifying issues for future product improvement.