The FDA has granted 510(k) clearance to the first robotic-assisted system for the treatment of CAD.
The system (CorPath 200, Corindus Vascular Robotics) allows interventional cardiologists to perform PCI in a cockpit using two joysticks to control the catheter and devices. According to a press release, the lead-lined cockpit protects physicians from radiation, while allowing them to operate without the use of leaded aprons that can cause orthopedic issues over time. The system also has the potential to enhance the view of the angiography screen.
In the prospective, single-arm, multicenter PRECISE trial, use of the robotic-assisted system was tested in 164 patients and resulted in successful completion of PCI without having to convert to manual PCI and without device-related complications in 98.8% of patients. Overall, the procedural success rate was 97.6%, while radiation exposure of the physician was reduced by 95%.