The US Food and Drug Administration (FDA) has granted 510(k) clearance to Corindus Vascular Robotics' CorPath 200 system, designed to restore blood flow to blocked arteries in patients with coronary artery disease.
The CorPath 200 system, which is designed for use in percutaneous coronary interventions (PCI) procedures, enables interventional cardiologists to place coronary guidewires and stent/balloon catheters from an optimized interventional cockpit that protects from exposure to harmful radiation.
The approval is based on a multi-center, prospective, single-arm CorPath PRECISE trial, designed to assess the safety and efficacy of CorPath 200 system.
The study demonstrated that robotically-assisted PCI is safe and feasible for patients and overall procedure success rate was 97.6%.
The study also found that PCI can reduce the radiation exposure by 95% when performing the procedure with the CorPath 200 system.
St. Elizabeth’s Medical Center cardiovascular medicine chief Joseph P. Carrozza said in the past, the center has relied on heavy lead aprons to protect from radiation, but the physical stress of wearing these aprons can lead to back pain, fatigue and orthopedic injuries.
"Robot-assisted PCI procedures allow us to provide our patients with the highest quality of care working in an ergonomic position with robotic-assisted stent and balloon placements to restore blood flow," Carrozza added.