FDA approves robotic-assisted PCI device
The FDA has granted 510(k) clearance to the Corindus Vascular Robotics' CorPath 200 system to be used during PCI procedures.
The technology is now approved in the U.S. to assist interventional cardiologists in performing PCI in patients with coronary artery disease (CAD).
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 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 the Natick, Mass.-based company.
At the 35th annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI) in Las Vegas in May, Giora Weisz, MD, director of clinical cardiovascular research at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City, presented the first data on using the device in a clinical setting as the late-breaking clinical trial PRECISE.
In the study, the researchers treated 164 patients at nine sites with robotically enhanced PCI using the CorPath 200. PCI was successfully completed without having to convert to manual PCI in 98.8 percent of patients, without device-related complications. The overall procedure success rate was 97.6 percent. For the effect on the operator, the median reduction in radiation exposure to the operator was 94.8 percent lower than the levels found at the standard table position.
The technology is now approved in the U.S. to assist interventional cardiologists in performing PCI in patients with coronary artery disease (CAD).
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 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 the Natick, Mass.-based company.
At the 35th annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI) in Las Vegas in May, Giora Weisz, MD, director of clinical cardiovascular research at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City, presented the first data on using the device in a clinical setting as the late-breaking clinical trial PRECISE.
In the study, the researchers treated 164 patients at nine sites with robotically enhanced PCI using the CorPath 200. PCI was successfully completed without having to convert to manual PCI in 98.8 percent of patients, without device-related complications. The overall procedure success rate was 97.6 percent. For the effect on the operator, the median reduction in radiation exposure to the operator was 94.8 percent lower than the levels found at the standard table position.