Corindus Vascular Robotics’ robotic-assisted percutaneous coronary interventions (PCI) system CorPath GRX has been approved by the Pharmaceutical and Medical Device Agency (PMDA) in Japan.
Citing figures from Millennium Research Group, Corindus says that Japan is a major market for PCI with nearly 250,000 PCI procedures carried out yearly.
Corindus president and CEO Mark Toland said: “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.
“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.”
Approved in the US in October 2016, CorPath GRX has been developed to enhance precision and workflow, and also for expanding capabilities and variety of procedures that can be executed robotically.
In April 2017, the first robotic-assisted PCI procedures were performed in Asia using the CorPath GRX system.
The second generation robotic system features a 1mm advancement capability, to help physicians to manage guide catheters independently and simultaneously from the workstation console.
According to Corindus, the precision positioning enables physicians to adjust guide catheters during PCI procedures, thereby helping to increase the use of the CorPath GRX System to cover complex cases.
Corindus said that it is trying to get reimbursement for robotic PCI through the insurance system in Japan and intends to carry out a post-market study of CorPath GRX, which will be launched by Corindus alongside its distribution partner, Japan MedicalNext.
Under an agreement made in early 2017, Japan Medicalnext is the exclusive distributor of Corindus’ products in Japan.
Headquartered in Waltham, Massachusetts, Corindus Vascular Robotics’ first FDA-approved medical device is the CorPath System, which has been developed with an objective to bring robotic precision to percutaneous coronary and percutaneous vascular procedures.