Corindus Receives FDA Clearance for First Automated Robotic Movement in technIQ™ Series for CorPath GRX Platform

WALTHAM, Mass., Corindus Vascular Robotics, Inc., a leading developer of precision vascular robotics, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the first automated robotic movement designed for the CorPath GRX platform.

The proprietary software feature, named "Rotate on Retract" (RoR), 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. Preclinical data presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in October 2017 demonstrated a significant reduction in wiring time among a highly-experienced group of physicians when comparing robotic wiring versus robotic wiring with RoR enabled.

Following the software's CE Mark approval in January 2018, interventional cardiologists Arif Al Nooryani, M.D. and Wael Aboushokka, M.D. of Al Qassimi Hospital in Sharjah, Dubai, UAE, performed the first percutaneous coronary interventional procedures (PCI) in the world using RoR. Today Nelson Bernardo, M.D., Medical Director of the Peripheral Vascular Laboratory at MedStar Heart Institute, will be performing a robotic-assisted peripheral intervention utilizing RoR, which will be broadcast live to the Cardiovascular Research Technologies (CRT) Meeting in Washington, D.C.

"This first-of-its-kind automation software has the potential to extend the clinical capabilities of CorPath GRX in more complex procedures," said J. Aaron Grantham, M.D., Chief Medical Officer of Corindus and practicing Interventional Cardiologist at Saint Luke’s Mid America Heart Institute. "Bringing consistency to interventional procedures through advanced wire movements has the opportunity to reduce procedure time and enhance patient outcomes."

Mark Toland, President and CEO of Corindus, stated, "FDA clearance of this new software feature marks the first step on our path to full autonomous navigation. Over the next several years, we will focus on automating the techniques of world-class physicians to make them available to every hospital with a vascular robotic program. We believe artificial intelligence through procedural automation will increase the value of robotics in the cath lab by reducing variability of treatment and procedure time, and improving the overall quality of patient care."