The FDA granted 510(k) clearance to the first automated robotic movement software designed for Corindus Vascular Robotics (OTC:CVRS) CorPath GRX percutaneous coronary intervention platform, the company reported today.
The Rotate on Retract feature allows the person operating the CorPath GRX to navigate to a targeted lesion by automatically turning the guidewire upon joystick retraction.
The software also won CE Mark approval in the European Union earlier this year. Today, Dr. Nelson Bernado, the medical director of MedStar Heart Institute’s Peripheral Vascular Laboratory, is slated to perform a robotic-assited peripheral intervention using the RoR feature. The procedure will be broadcast live to the Cardiovascular Research Technologies meeting in Washington, D.C., according to Corindus.
“This first-of-its-kind automation software has the potential to extend the clinical capabilities of CorPath GRX in more complex procedures,” Dr. J. Aaron Grantham, Corindus’ chief medical officer, said in prepared remarks. “Bringing consistency to interventional procedures through advanced wire movements has the opportunity to reduce procedure time and enhance patient outcomes.”
“FDA clearance of this new software feature marks the first step on our path to full autonomous navigation,” president & CEO Mark Toland added. 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.”