Corindus’ CorPath GRX Seeks Premarket FDA Clearance for Neurovascular Intervention
February 14, 2019—Corindus Vascular Robotics, Inc. announced that it is seeking premarket clearance from the FDA for a neurovascular intervention (NVI) indication for its CorPath GRX system.
The CorPath system is an FDA-cleared, robot-assisted platform that brings robotic precision to percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). If approved by the FDA for the NVI indication, CorPath GRX will be the first and only robotic platform indicated for use in PCI, PVI, and NVI, according to the company.
Along with Corindus’ establishment of a neuroendovascular sector last year, this indication to treat neurovascular conditions will mark the company’s move toward revolutionizing stroke treatment. Aquilla Turk, MD, Corindus’ Chief Medical Officer, commented, “The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics. Applying the benefits of robotic precision to neurovascular intervention, while building a wealth of clinical knowledge and expertise, are key to preparing for a future of remote stroke treatment.”
Last December, the CorPath GRX technology was successfully used in the GRX With ReMOTE study, which was the first-in-human, telerobotic PCI conducted from a remote location outside of the catheterization lab.