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FDA clears robotic-assisted system for CAD stent procedures
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Corindus Vascular Robotics today announced FDA clearance of the CorPath 200 System to be used in percutaneous coronary interventions.
The CorPath 200 System is the first robotic-assisted procedure to allow for controlled placement of coronary guidewires and stent/balloon catheters from an optimized interventional cockpit. The lead-lined cockpit protects the interventional cardiologist from harmful radiation exposure and the seated position in front of monitors may provide enhanced view of the angiography screen while reducing fatigue and minimizing head, neck and back strain, according to a press release.
“This is an important milestone for interventional cardiologist as we take the next step in transforming the way these procedures are performed in the future,” David M. Handler, president and CEO of Corindus Vascular Robotics, stated in the release.
The prospective, single-arm, multicenter CorPath PRECISE trial served as the basis for submission of a premarket clearance application to the FDA. Results demonstrate that robotically assisted PCI was safe and feasible for patients. PCI was successfully completed without having to convert to manual PCI in 98.8% of patients, without device-related complications. The overall procedure success rate was 97.6%. Additionally, results showed that robotically assisted PCI can make the procedure safer for the interventional cardiologist by reducing radiation exposure by 95%, according to information in the release.
“Working with this robotic technology is very intuitive … the PRECISE trial demonstrated its applicability in today’s cath lab environment,” Giora Weisz, MD, director of clinical research at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center and associate professor of medicine at Columbia University College of Physicians and Surgeons, stated in the release. “I strongly believe robotic-assisted PCI will enhance the way we are conducting PCI, and we are looking forward to adapting it in our everyday practice.”