September 24, 2010 - The first in-human study of a robotically assisted percutaneous coronary intervention system demonstrated that the technique is safe and feasible. The results of the study, which used the CorPath 200 by Corindus Vascular Robotics, were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting.
Currently, percutaneous coronary intervention (PCI) still presents multiple limitations and potential hazards for both the patient and the operator. According to the study, robotically assisted PCI demonstrates the potential to decrease radiation exposure, contrast media usage and improve technical precision.
Using a remote system that is capable of advancing, retracting, and rotating 0.014-inch guidewires and rapid exchange catheter systems, the operator manipulates the devices from a control console with joysticks while sitting comfortably at the radiation-shielded interventional cockpit.
“Use of robotics is a very exciting development in interventional cardiology,” said Juan F. Granada, M.D., co-leader of the study and executive director and Chief Scientific Officer of The Jack H. Skirball Center for Cardiovascular Research at the Cardiovascular Research Foundation. “The operator is able to perform the procedure from a remote, radiation-protected control console. Initial experience with the use of this system demonstrated procedural effectiveness that was comparable to manual PCI.”
Eight patients were enrolled in the study, which was performed at the Corbic Research Institute in Envigado, Colombia. All had evidence of myocardial ischemia, documented de novo coronary stenosis and clinical indication for PCI.
All patients met the safety and technical success endpoint criteria. The robotic system demonstrated a performance success of 97.8 percent in completing 48 procedural steps (47 out of 48). There were no instances of in-hospital or 30 days follow-up MACE or any other device or procedure-related adverse events. In seven of the eight cases, the operators consistently scored the robotic performance as equal to manual operation. Compared to published data, average contrast media use was lower, and the operator exposure to radiation was 97 percent lower than at the table position.
This initial trial will be followed by a multi-center U.S. study. The PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention Study) study, led by co-principal investigators, Giora Weisz, M.D., and Joseph Carozza, M.D. (St. Elizabeth, Boston), will aim to prove the safety and efficacy of the robotically assisted PCI system in a larger group of patients.
For more information please visit: www.crf.org.