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October 30, 2016

Corindus secures FDA 510(k) clearance for CorPath GRX robotic system

US-based Corindus Vascular Robotics has secured the US Food and Drug Administration (FDA) 510(k) clearance to market its CorPath GRX robotic system.

US-based Corindus Vascular Robotics has secured the US Food and Drug Administration (FDA) 510(k) clearance to market its CorPath GRX robotic system.

The CorPath System has been developed to assist interventional cardiologists to perform percutaneous coronary intervention (PCI).

During robotic-assisted PCI, physicianscan  use joysticks and touchscreen controls sitting in a radiation-shielded workstation, the Interventional Cockpit, to robotically control guidewires and balloon / stent catheters during an intervention.

"This is a tremendous advancement in the technology platform that will greatly extend the clinical capability of the system."

A component of CorPath platform, the CorPath GRX has been upgraded with features such as the Active Guide Management enabling control of the guide catheter along with robotically controlling of the guidewire and balloon or stent catheter, with one-millimeter advancement, from the control console.

This precise positioning will enable adjustment of guide catheter position during PCI procedures and can also expand the usage of CorPath for more complex cases.

CorPath GRX has also been incorporated with a redesigned bedside unit featuring an extended reach arm and a touchscreen display to streamline workflow.

Corindus chief medical officer 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.

“This is a tremendous advancement in the technology platform that will greatly extend the clinical capability of the system."

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