ROBOTIC ASSISTED PCI: RESULTS OF THE PRECISE TRIAL USING THE CORPATH, REMOTE DELIVERY SYSTEM
George W. Vetrovec, M.D., VCU Pauley Heart Center, Richmond, VA, USA
While success and safety of PCI has increased significantly, there are still opportunities to improve PCI outcomes. One isuse of the Corpathrobotic PCI system. Potential benefits include less patient radiation exposure, lower contrast use, improved stent length sizing as well as lower operator radiation exposure and orthopedic risk.
The Corpath system consists of a disposable, table mounted, guidewire and stent delivery device controlled remotely from a radiation shielded cabin using a joystick as part of a precise response control system. The operator is able to advance and steer the guidewire and advance a balloon or stent without “on body” radiation protection from a console remote from the cath table.
Initial experience with the system includes athree vessel swine PCI trial comparing Robotic to POBA. There was no difference in success or safety but less contrast administration in the Robotic group.
A “First in Man” trial at the Corbic Institute(Medellin, Colombia) involved 8 subjects. Again safety and efficacy were confirmed for the Corpath system. Furthermore, when these results were compared to a historical control group, there were similar outcomes.
The pivotal USA multicenter, prospective, single arm trial (PRECISE) performed by 9 centers in the USA has now completed enrollment of over 160 patients.Preliminary data suggests a high level of success. Complete data for this pivotal trial will be presented at the meeting.
In summary, preliminary data support the safety and effectiveness of the Corpath Robotic PCI System. The system has significant potential patient benefits forreduced radiation exposure and contrast use while limiting operator radiation and orthopedic stress.