Corindus Vascular Robotics' CorPath System Cleared for Radial Access PCI

October 6, 2015—Corindus Vascular Robotics, Inc. announced that the US Food and Drug Administration has given 510(k) clearance for the company’s robotic-assisted CorPath system to be used during percutaneous coronary interventions (PCIs) performed via radial access. 

The company noted that the 510(k) clearance was based on results of a clinical trial composed of 30 patients and demonstrated 100% device and clinical success. The trial was conducted at Spectrum Health in Grand Rapids, Michigan, and St. Joseph's Hospital Health Center in Syracuse, New York. 

Ryan Madder, MD, an interventional cardiologist at the Frederik Meijer Heart & Vascular Institute of Spectrum Health, commented in the company’s announcement, “Radial access is a critical technique to improve patient experience and reduce postprocedural complications. It will doubtless become the predominant approach in the United States as it has abroad. I routinely use the CorPath system in radial PCI and have found it to be useful in reducing my radiation exposure in these radial cases. Minimizing operator radiation in these cases is particularly important considering that some studies have shown radial access to be associated with increased radiation exposure.” 

According to Corindus, the radial approach delivers similar procedural success as femoral PCI procedures, but with fewer access site or vascular complications. Studies also demonstrate that radial PCI procedures can significantly reduce hospital stays and associated costs. 

Additionally, although radiation exposure to patients during PCI procedures is similar regardless of access site, the REVERE trial demonstrated that interventional cardiologists are exposed to significantly higher levels of radiation while performing left radial as opposed to femoral access procedures, advised the company.

The randomized noninferiority REVERE trial evaluated radiation exposure during cardiac catheterization comparing femoral access with left radial access and right radial access. In August 2015, Samir B. Pancholy, MD, et al published the REVERE findings in the Journal of the American College of Cardiology: Cardiovascular Interventions (2015;8:1189–1196).