Corindus' CorPath GRX Robotic PCI System Approved in Japan
June 8, 2018—Corindus Vascular Robotics, Inc. announced that it received Japan's Pharmaceutical and Medical Device Agency (PMDA) approval for commercialization of its CorPath GRX robotic percutaneous coronary intervention (PCI) system. Additionally, Corindus is pursuing reimbursement for robotic PCI through the Japanese insurance system and plans a postmarket study of CorPath GRX, which is the second generation of the company's CorPath vascular robotic system.
In early 2017, Corindus announced a strategic relationship with Japan Medicalnext Co., Ltd., a wholly owned entity of MC Healthcare, Inc. (a subsidiary of Mitsubishi Corporation), to become the exclusive distributor of Corindus products in Japan.
Takafumi Ueno, MD, commented in the company's press release, "I look forward to offering CorPath GRX to my patients during PCI, especially in complex procedures where precision and procedural control are extremely valuable. We are pleased to be one of the first Asia-Pacific countries to adopt this new and innovative technology." Dr. Ueno is Director of Interventional Cardiology, Center of Cardiovascular Disease, at Kurume University Hospital in Kurume, Fukuoka prefecture, Japan.