PRECISE Results Published for Corindus CorPath 200 System

April 9, 2013—Giora Weisz, MD, et al published findings from the PRECISE study in the Journal of the American College of Cardiology (2013;61:1596–1600). The aim of the PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) study was to evaluate the safety as well as the clinical and technical effectiveness of the CorPath 200 system (Corindus Vascular Robotics, Natick, MA) for robotic-assisted percutaneous coronary intervention (PCI).

According to the investigators, robotic systems have been suggested to enhance the performance of cardiovascular procedures, as well as to provide protection from the occupational hazards that are associated with interventional practice. The CorPath 200 robotic system consists of a remote interventional cockpit and a bedside disposable cassette that enables the operator to advance, retract, and rotate guidewires and catheters.

As summarized in the Journal of the American College of Cardiology, the PRECISE investigators at nine sites enrolled 164 patients with coronary artery disease and clinical indications for PCI. The patients were treated with PCI using the CorPath 200 system. The primary endpoints were clinical procedural success, defined as < 30% residual stenosis at the completion of the robotic-assisted procedure without major adverse cardiovascular events within 30 days, and device technical success, defined as the successful manipulation of the intracoronary devices using only the robotic system.

The investigators reported that PCI was completed successfully without conversion to manual operation, and device technical success was achieved in 162 of 164 patients (98.8%). There were no device-related complications. Clinical procedural success was achieved in 160 of 164 patients (97.6%). Four patients (2.4%) had periprocedural non–Q-wave myocardial infarctions. No deaths, strokes, Q-wave myocardial infarctions, or revascularization occurred in the 30 days after the procedures. Radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position.

The pivotal multicenter PRECISE study demonstrated the safety and feasibility of robotic-enhanced PCI with the CorPath 200 system by meeting the expected technical and clinical performance endpoints with significantly lower radiation exposure to the operator, concluded the investigators in the Journal of the American College of Cardiology.

In July 2012, Corindus announced that the US Food and Drug Administration granted 510(k) clearance for the CorPath 200 system to be used in PCI. In August 2012, Corindus announced a distribution agreement with Royal Philips Electronics (Amsterdam, The Netherlands), which owns a minority share in Corindus, that enables both companies to sell the CorPath 200 system in the United States. The PRECISE data were first presented in May 2012 at the Society for Cardiovascular Angiography and Interventions Scientific Sessions in Las Vegas, Nevada.