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Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan
Takeshi Shiba1, Koichi Aizawa1, Mami Ho2
1Pharmaceuticals and Medical Devices Agency.
Insights
The CorPath GRX system, a robotic-assisted device for percutaneous coronary intervention (PCI), demonstrated effectiveness and safety in Japanese real-world use. Real-world data collection is crucial for product improvement and understanding clinical application.
Area of Science:
- Cardiovascular Medicine
- Medical Technology
- Interventional Cardiology
Background:
- The CorPath GRX system, a robotic-assisted platform for percutaneous coronary intervention (PCI), received approval in Japan in 2018.
- Approval was based on international clinical studies of the first-generation system, with limited prior experience of remote control PCI devices in Japan.
Purpose of the Study:
- To confirm the efficacy and safety of the CorPath GRX system in Japanese real-world clinical practice.
- To evaluate the implementation of necessary measures for appropriate operator and facility use, including guidelines and training.
Main Methods:
- A use-results survey was conducted to gather data on the CorPath GRX system's performance in Japanese clinical settings.
- Data collection focused on efficacy, safety, and adherence to implementation protocols.
Main Results:
- The survey confirmed the effectiveness and safety of the CorPath GRX system in Japanese patients undergoing PCI.
- Some procedural implementation characteristics in Japan differed from those reported in international studies.
Conclusions:
- Real-world data collection is valuable for assessing product safety and efficacy post-approval.
- Identifying real-world implementation variations can guide future product enhancements and clinical practice improvements.
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.
