FDA Clears Automated Robotic Movement Software for Corindus' CorPath GRX Platform

March 5, 2018—Corindus Vascular Robotics, Inc. announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its automated robotic movement technology designed for the CorPath GRX platform. The company's "Rotate on Retract" (RoR) software feature is the first automated robotic movement in the technIQ Series for the CorPath GRX platform. It allows the operator to quickly navigate to a targeted lesion by automatically rotating the guidewire upon joystick retraction.

According to the company, preclinical data presented last year at the TCT 2017, the Transcatheter Cardiovascular Therapeutics conference, demonstrated a significant reduction in wiring time among a highly experienced group of physicians when comparing robotic wiring versus robotic wiring with RoR enabled.

Corindus stated that after the software received CE Mark approval in January 2018, interventional cardiologists Arif Al Nooryani, MD, and Wael Aboushokka, MD, of Al Qassimi Hospital in Sharjah, Dubai, United Arab Emirates, performed the first percutaneous coronary intervention procedures using RoR. On March 5, Nelson Bernardo, MD, will perform a robotic-assisted peripheral intervention utilizing RoR that will be broadcast live to the CRT 18, the Cardiovascular Research Technologies Meeting held March 3–6 in Washington, DC.