FDA approves CorPath 200 (Corindus Inc) robotic-assisted system for PCI - 28-Jul-2012

The FDA has given 510(k) clearance for the CorPath 200 System, from Corindus Inc, to be used in Percutaneous Coronary Interventions (PCI). The technology is now approved in the US to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with Coronary Artery Disease (CAD).

The CorPath PRECISE Trial—a prospective, single-arm, multi-center,study, which served as the basis for the submission of a pre-market clearance (510(k)) application to the FDA—demonstrated that robotically-assisted PCI is safe and feasible for patients. PCI was successfully completed without having to convert to manual PCI in 98.8 percent of patients and without device-related complications. The overall procedure success rate was 97.6 percent. Additionally, the trial found that robotic-assisted PCI can make the procedure safer for the interventional cardiologist by reducing the radiation exposure by 95 percent when performing the procedure with the CorPath 200 System.

The System is the first and only 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.