FDA Clears the Next-Generation Corindus CorPath GRX Vascular Robotic System

October 27, 2016—Corindus Vascular Robotics, Inc. announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its CorPath GRX, the second generation of its CorPath vascular robotic system. Corindus expects to begin commercialization of CorPath GRX in the first quarter of 2017.

CorPath GRX builds upon the CorPath platform with key upgrades that increase precision, improve workflow, and extend the capabilities and range of procedures that can be performed robotically. These features include active guide management, which enables control of the guide catheter along with robotic control of the guidewire and balloon or stent catheter—with 1-mm advancement—from the control console.

The company stated that this precise positioning will enable physicians to adjust the guide catheter position during percutaneous coronary intervention procedures and may expand use of CorPath to more complex cases. CorPath GRX also features a redesigned bedside unit featuring an extended reach arm and a touchscreen display to streamline workflow.

The Corindus CorPath system’s robotic precision for percutaneous coronary interventions protects medical professionals from radiation exposure that occurs in hospital catheterization labs, stated the company.