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FDA Greenlights First Robotic PCI System

Fri, 07/27/2012 - 4:54am

The FDA has approved the first robotic-assisted percutaneous coronary intervention (PCI) system, the CorPath 200, according to manufacturer Corindus Vascular Robotics.

The 510(k) clearance by the FDA comes on the strength of the PRECISE trial, a prospective, single-arm, multicenter study whose results were presented in May at the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).

Of the 162 procedures performed with the robotic technology in PRECISE, only two cases had to be converted to manual stent implantation -- and the fault was not that of the robotic system, Giora Weisz, MD, of Columbia University Medical Center in New York City, reported at the time.

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