FDA grants 510(k) clearance to the CorPath System for radial access PCI

The FDA gave a 510(k) clearance on Oct. 6 to the CorPath System for use during PCIs performed via radial access. 

Approximately 40 percent of PCIs in the U.S. use the radial approach, according to Corindus Vascular Robotics, Inc., the CorPath’s manufacturer.

The approval was based on results of a trial in which all 30 patients enrolled had device and clinical success. The study took place at Spectrum Health in Grand Rapids, Mich. and St. Joseph’s Hospital Health Center in Syracuse, N.Y.

In July 2012, the FDA granted 510(k) clearance to the CorPath System for use during PCIs. The CorPath System is the first system designed for robotic-assisted PCIs.

With the CorPath System, physicians sit in a radiation-shielded cockpit and use joysticks and controls to measure anatomy length and select the appropriate stent. A bedside unit translates physicians’ commands into precise movements and manipulations of the coronary stents and catheters.