The US Food and Drug Administration (FDA) has granted 510(k) clearance to Corindus Vascular Robotics' CorPath 200 system, designed for use in percutaneous coronary intervention (PCI) procedures to restore blood flow to blocked arteries in patients with coronary artery disease.
The CorPath 200 system enables interventional cardiologists to place coronary guidewires and stent / balloon catheters from an optimised interventional cockpit which protects from exposure to harmful radiation.
Joseph P. Carrozza, St. Elizabeth's Medical Centre cardiovascular medicine chief, said in the past, the centre 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.
The approval is based on a multicentre, prospective, single-arm CorPath PRECISE trial, designed to assess the safety and efficacy of the 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.
Giora Weisz, NewYork-Presbyterian Hospital / Columbia University Medical Centre interventional vascular therapy clinical research director and Columbia University College of Physicians and Surgeons medicine associate professor, said the performance and the control of the CorPath 200 system, including manipulating the guidewire and stent, enables them to move the devices in increments as small as one millimetre.
"Working with this robotic technology is very intuitive and the PRECISE trial demonstrated its applicability in today's cath lab environment," Weisz added.
"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."
Image: The CorPath 200 system for use in PCI procedures restores blood flow in blocked arteries of coronary artery disease patients. Photo courtesy of: Corindus, Inc.