FDA Clears Corindus Vascular Robotics CorPath 200 System for PCI
July 25, 2012—Corindus Vascular Robotics (Natick, MA) announced that the US Food and Drug Administration (FDA) granted 510(k) clearance for the CorPath 200 system to be used in percutaneous coronary interventions (PCI).
According to the company, robotic-assisted PCI with the CorPath 200 system allows for controlled placement of coronary guidewires and stent/balloon catheters from an optimized interventional cockpit. The lead-lined cockpit protects the interventionist from radiation exposure. 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.
Joseph P. Carrozza, Jr, MD, who is Chief of Cardiovascular Medicine at St. Elizabeth's Medical Center in Boston, Massachusetts, commented on the system in the company’s press release.
"The FDA clearance of the CorPath System will truly change the way I am able to practice. As interventional cardiologists, we perform our procedures using X-ray guidance and are cognizant that throughout our careers, we will be exposed to a high amount of radiation,” stated Dr. Carrozza. “In the past, we have relied on heavy lead aprons to protect us 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."
In its press release, Corindus noted that the CorPath PRECISE trial served as the basis for the submission of the 510(k) premarket clearance application to the FDA. The company stated that this prospective, single-arm, multicenter study 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% of patients and without device-related complications. The overall procedure success rate was 97.6%. Additionally, the trial found that robotic-assisted PCI can make the procedure safer for the interventionist by reducing the radiation exposure by 95% when performing the procedure with the CorPath 200 system.
“Gaining significant experience with the CorPath 200 System, I was impressed with its performance and the precise control of the interventional devices, including manipulating the guidewire and stent, and being able to move the devices precisely in increments as small as one millimeter,” commented Giora Weisz, MD, in the press release. “Working with this robotic technology is very intuitive and the PRECISE trial demonstrated its applicability in today's cath lab environment. 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.” Dr. Weisz is 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 in New York City.