FDA Grants 510(k) Clearance to Corindus Vascular Robotics for CorPath System

The FDA has granted 510(k) clearance to Corindus Vascular Robotics for its robotic-assisted CorPath System to be used during percutaneous coronary interventions.

The clearance follows the successful results of a 30-patient clinical trial conducted at Spectrum Health in Grand Rapids, Mich. and St. Joseph’s Hospital Health Center, Syracuse, N.Y., that demonstrated 100 percent device and clinical success.

The system enables the precise control of coronary guidewires and balloon and stent devices from a radiation-protected, ergonomic interventional cockpit, according to the company. —Michael Cipriano