www.fdanews.com/articles/175938-corpath-robotic-system-secures-fda-clearance
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CorPath Robotic System Secures FDA Clearance
March 29, 2016
The FDA has granted Corindus Vascular Robotics 510(k) clearance for its CorPath Robotic System for use in peripheral vascular interventions.
Previously, the system was cleared for percutaneous coronary intervention and radial PCI.
The clearance was backed by results from a clinical trial evaluating 20 patients with symptomatic disease, in which the system demonstrated 100 percent device and clinical success, the company says. — Anisa Jibrell