Robotically Assisted PCI System -- COMPAMED Trade Fair

The current practice of percutaneous coronary intervention (PCI) still presents multiple limitations and potential hazards for both the patient (radiation exposure, contrast media use) and the operator (spine strain, accumulated radiation). According to the study, robotically-assisted PCI demonstrates the potential to decrease radiation exposure, contrast media usage and improve technical precision.

The study was led by Doctor Juan F. Granada, Executive Director and Chief Scientific Officer of The Jack H. Skirball Center for Cardiovascular Research and Doctor Giora Weisz, Director of Clinical Cardiovascular Research at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital.

"Use of robotics is a very exciting development in interventional cardiology," said Granada. "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."
In the study, a total of eight patients were enrolled in a single arm, open label, prospective study. All patients had evidence of myocardial ischemia, documented de novo coronary stenosis, and clinical indication for PCI.

Using a remote system that is compatible and capable of advancing, retracting, and rotating 0.014" guidewires and rapid exchange catheter systems, the operator manipulates the interventional devices from a control console with joysticks while sitting comfortably at the radiation-shielded interventional cockpit.
The primary endpoint was technical success (< 30 percent final diameter stenosis) after using the robotic angioplasty system to deliver a balloon and a stent to the target lesion, and successfully retracting the devices without the occurrence of any in-hospital MACE (cardiac death, myocardial infarction, or clinically driven target vessel revascularization).

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 7 of the 8 cases, the operators consistently scored the robotic performance as equal to manual operation. Compared to published data, average contrast media use was lower. The operator exposure to radiation was 97 percent lower than at the table position.; Source: Cardiovascular Research Foundation