FDA Approves Robotic-Assisted System For Radial Access PCI
The U.S. Food and Drug Administration (FDA) gave 510(k) clearance on Oct. 6 for the robotic-assisted CorPath System from Corindus Vascular Robotics, Inc. The system is intended for use during radial access percutaneous coronary interventions (PCI).
In clinical trial, the CorPath system showed 100 percent device and clinical success. The device also offers protection for interventional health care providers from radiation exposure during PCI.
According to David Handler, president and chief operating officer of Corindus, “the CorPath System's ability to protect cath lab personnel during these cases is more important than ever with the increasing prevalence of radial and complex PCI in today's cath lab.”
Keywords: Coronary Angiography, Percutaneous Coronary Intervention, Robotics, United States Food and Drug Administration
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