Premarket Clearance Request Filed for Robotic Neurovascular Intervention

Friday, February 15, 2019

A premarket clearance request for a neurovascular intervention platform (CorPath GRX System; Corindus Vascular Robotics, Waltham, MA) has been filed with the Food and Drug Administration (FDA). Already cleared for use in peripheral vascular interventions (PVI) in 2018 and percutaneous coronary intervention (PCI) in 2016, this platform provides robotic-assisted control and placement of catheters, guidewires, and stents with submillimeter precision. With both a radiation-protective workstation and a bedside touchscreen, the platform provides a flexible approach to endovascular interventions. If cleared, it will be the only robotic platform indicated for use in PCI, PVI and NVI.

As the longer treatment windows and evidence-based improvements in outcomes for many neurovascular indications continue to increase, having precision tools available becomes ever more important. Use of robotics also opens the door for teleneurology mechanical thrombectomy, thought by some to be the next big advancement in stroke care to come. Trials for remote PCI with this system are already underway.

“The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics,” said Aquilla Turk, DO, chief medical officer at Corindus Vascular 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.”

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