Corindus Receives FDA Clearance for First Automated Robotic Movement for CorPath GRX Platform

Corindus Vascular Robotics Inc., a developer of precision vascular robotics, has 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.

“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.”
 
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.
 
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 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.”
 
Corindus Vascular Robotics Inc. develops robotic-assisted vascular interventions. The company’s CorPath System is the first FDA-cleared medical device to bring robotic precision to percutaneous coronary and percutaneous vascular procedures. During the procedure, the interventional cardiologist sits at a radiation-shielded workstation to advance guide catheters, stents, and guidewires with millimeter-by-millimeter precision. The workstation allows the physician greater control and the freedom from wearing heavy lead protective equipment that causes musculoskeletal injuries. CorPath GRX is the second generation robotic-assisted PCI technology offering enhancements to the platform by adding important key upgrades that increase precision, improve workflow, and extend the capabilities and range of procedures that can be performed robotically. With the CorPath System, Corindus Vascular Robotics brings robotic precision to interventional procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement during manual procedures.