The CorPath Vascular Robotic System, developed by Corindus Vascular Robotics, is intended for use in the remote delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary interventional (PCI) procedures.
Contents
Overview
The CorPath System consists of two main components. The bedside unit is attached to the patient table and comprises an articulating arm, robotic-drive, and single-use sterile cassette. The lead-lined interventional cockpit is typically placed beside the patient table and houses the control console and imaging monitors.
The interventional cardiologist sits at the cockpit and remotely performs the PCI using the console joysticks or touch-screen buttons. Commands from the control console are delivered as electrical signals along a communication cable that runs from the control console to the robotic drive, on which a sterile cassette is placed. The cassette, which is loaded with the interventional devices and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices. The robotic-assisted system is compatible with all commercially available 0.014-inch guidewires, rapid-exchange coronary angioplasty balloons, and stent delivery systems.
The system was evaluated in a single arm single-arm, multicenter, open-label, nonrandomized study. The objectives of the PRECISE study were to evaluate the safety, clinical, and technical performance of the robotic system in the delivery and manipulation of coronary guidewires, balloons, and stents for PCI. The product was cleared by the U.S. Food and Drug Administration (FDA) in July 2012.
Summary
In April 2011, the First in Man Trial (FIM) for the CorPath 200 System was published in the Journal of the American College of Cardiology. This clinical study enrolled eight patients with coronary artery disease who required a PCI procedure at the Corbic Research Institute in Envigado, Colombia. All patients were treated for a single de novo coronary lesion up to 25mm in length located in a vessel 2.5-4.0mm in diameter.
Results
The procedure was successfully completed in all 8 patients utilizing the CorPath System to advance coronary guidewires and perform the intervention; there were no reported device or procedure-related complications/major adverse cardiac events. Operator radiation exposure was 97% lower with the use of the CorPath System in comparison with levels found at the standard table position.
Introduction
Continuing from the foundations of the FIM study, the CorPath Percutaneous Robotically- Enhanced Coronary Intervention Study (PRECISE) aimed to expand and verify safety and technical efficacy of CorPath System use in the robotic manipulation of coronary guidewires and stent/balloon systems. The PRECISE trial was conducted under Principal Investigators, Giora Weisz, Director of Clinical Cardiovascular Research at the Center for Interventional Vascular Therapy at NewYork Presbyterian Hospital/Columbia University Medical Center and Joseph Carrozza, Chief of Cardiovascular Medicine at St. Elizabeth’s Medical Center in Boston. Criteria for participation included patients 18–99 years old, male or female, with a single de novo stenosis >50%, occlusions under 25 mm long in vessels 2.5 to 4 mm in diameter, by visual estimate. The CorPath PRECISE Study was sponsored by Corindus Vascular Robotics under Investigational Device Exemption (IDE) approval from the FDA to obtain 510(k) clearance. The study was a prospective, multicenter, open-label, non-randomized study, enrolling 164 patients at nine clinical trial sites. Physicians participating in the study did not receive any direct financial compensation.
Results
Results of the CorPath PRECISE trial were published in the April 2013 issue of the Journal of the American College of Cardiology. The study reported a successful PCI completion with use of the CorPath System in 162 of the total 164 cases. In the two outstanding cases, the interventionalist left the CorPath cockpit to complete the procedure manually, resulting in an incomplete use of the CorPath System, but clinically successful procedures. There were no reports of device-related complications and an overall clinical success rate of 97.6%. [7] [6] The average radiation exposure to the cardiovascular interventionalist decreased by 95.2%, in contrast to levels reported during standard interventions.
FDA Clearance
Corindus Vascular Robotics received FDA 510(k) clearance for the CorPath System to be used in percutaneous coronary interventions (PCI) on July 25, 2012. The technology is now approved in the United States to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with coronary artery disease (CAD). The PRECISE Trial served as the basis for the submission of a premarket clearance (510(k)) application to the FDA—demonstrating that robotically-assisted PCI is both safe and feasible for patients. The overall clinical procedure success rate was 97.6%, while reducing the radiation exposure by 95.2% for interventionalists performing the procedure with the CorPath System.
Criticism
The benefits of robotic-assisted PCI to the occupational health of the interventional cardiologist are widely accepted. Criticism of the technology mainly has to do with a lack of clinical evidence and cost. The 164-patient multicenter PRECISE study did demonstrate the safety and effectiveness of the CorPath System and while there has been rapid adoption of robotic-assisted PCI, there have been no randomized trials comparing its safety and efficacy to traditional angioplasty.
Although initial data suggests that the CorPath System may lead to a reduction in stent usage and other consumables when compared to historical data and that the cost may be justified, no well-designed randomized trial has examined the economics of the investment.