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Corindus Announces Pharmaceutical and Medical Device Agency (PMDA) Approval of CorPath GRX System in Japan

Gabrielle Lakusta
Jun. 08, 2018 09:17AM PST
Medical Device Investing

Corindus Vascular Robotics [NYSE:CVRS], a leading developer of precision vascular robotics, announced today that it received Pharmaceutical and Medical Device Agency (PMDA) Approval for commercialization of its CorPath® GRX System in Japan. Japan is one of the largest markets in the world for percutaneous coronary interventions (PCI) with approximately 250,0001 PCI procedures performed annually. As quoted in the …

Corindus Vascular Robotics [NYSE:CVRS], a leading developer of precision vascular robotics, announced today that it received Pharmaceutical and Medical Device Agency (PMDA) Approval for commercialization of its CorPath® GRX System in Japan. Japan is one of the largest markets in the world for percutaneous coronary interventions (PCI) with approximately 250,0001 PCI procedures performed annually.

As quoted in the press release:

Corindus is actively pursuing reimbursement for robotic PCI through the Japanese insurance system and plans a post-market study of CorPath GRX. In early 2017, Corindus announced a strategic relationship with Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. (subsidiary of Mitsubishi Corporation), to become the exclusive distributor of Corindus products in Japan, bringing robotic precision and control to the large and growing PCI segment of the Japanese healthcare market.

“There is strong demand for robotic-assisted intervention from Key Opinion Leaders (KOLs) and the broad clinical community in Japan. PMDA approval of CorPath GRX in Japan represents a significant step in our ongoing effort to bring cutting-edge vascular robotics to global markets,” stated Mark Toland, President and Chief Executive Officer. “We believe robotics has the potential to enhance patient care in Japan by offering the benefits of robotic precision and advanced tools for physicians to perform these life-saving procedures.”

Click here to read the full press release.

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