Corindus Vascular Robotics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its next generation robotic system, CorPath GRX.
The company plans to commercialize the second generation CorPath vascular robotic system in the first quarter of next year.
CorPath system is claimed to be the only FDA-cleared medical device to bring robotic precision to percutaneous coronary interventional (PCI) procedures.
CorPath GRX includes advanced features, including active guide management that allows to control guide catheter along with robotic control of the guidewire and balloon or stent catheter with one-millimeter advancement from the control console.
Designed for use in more complex cases, the CorPath GRX allows physicians to adjust guide catheter position during PCI procedures.
The new system also features an advanced bedside unit, which includes an extended reach arm and touchscreen display to streamline workflow.
Corindus Vascular Robotics president and CEO Mark Toland said: “CorPath GRX is a critical advancement in our core technology and a meaningful step toward realizing our vision of fundamentally changing how PCI procedures are performed.
"GRX will enable us to build more robust and sustainable cardiovascular robotic programs with our hospital partners as we remain focused on providing the highest level of care to patients while protecting the health and wellness of the cath lab staff.”
Corindus chief medical officer Dr Aaron Grantham said: "The new features of the next generation CorPath System, particularly the addition of active guide catheter management, will allow physicians to increase the complexity of procedures performed robotically.”