Data Published on Corindus CorPath 200 Robotic PCI System

April 15, 2011—Findings from a first-in-human study that aimed to evaluate the safety and feasibility of the CorPath 200 remote-controlled, robotic angioplasty system (Corindus, Inc., Natick, MA) in the delivery and manipulation of coronary guidewires, balloons, and stents in patients undergoing elective percutaneous coronary intervention (PCI) were published by Juan F. Granada, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2011;4:460–465).

The investigators noted that the CorPath 200 system is under development to address some of the procedural challenges and occupational hazards associated with traditional PCI. These data were initially announced in September 2010, as reported in Cardiac Interventions Today.

As detailed by the investigators, the CorPath 200 robotic system features a remote interventional cockpit and a multicomponent bedside unit that enables the operator to advance, retract, and rotate guidewires and rapid-exchange catheters.

The study enrolled eight patients with coronary artery disease and clinical indications for elective PCI, and the coronary angioplasty procedures were performed with the CorPath 200.

The primary endpoint was device clinical success (30% residual stenosis) without in-hospital major adverse cardiac events. Technical success was defined as the ability of the system to complete all of the planned angioplasty steps on the basis of procedural segments. Patients were followed for 30 days after the angioplasty procedure.

The investigators reported that the primary endpoint was achieved in all patients (100%). The technical success of the robotic system was 97.9% in completing 47 of 48 planned steps. There were no device- or procedure-related complications and no in-hospital or 30-day major adverse cardiac events. The operators rated the robotic system performances as equal to or better than manual procedures in 97.5% of the cases. The operator radiation exposure was 97% lower than the levels found at the standard table position.

Early clinical experience with a robotic-assisted angioplasty system showed feasibility, safety, and procedural effectiveness comparable to manual operation, the investigators concluded. In addition, the total operator exposure to radiation was significantly low. A larger study is warranted to verify the safety and effectiveness of robotic-assisted PCI, the investigators advised.

Corindus recently announced that enrollment has commenced for the PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study) trial of the CorPath 200 system. The trial is a prospective, single-arm, multicenter study, which will initially enroll 154 patients. Investigators will evaluate the safety and effectiveness of the CorPath 200 system in delivering and manipulating coronary guidewires and stent/balloon systems in PCI procedures. Giora Weisz, MD, and Joseph P. Carrozza, MD, are the trial's coprincipal investigators. The results of this study will be the basis for a premarket clearance 510(k) application to the US Food and Drug Administration. The agency approved the trial, which was reported in January in Cardiac Interventions Today.

“I am pleased to lead and take part in a trial that is addressing a long time need in the cath lab—improved safety and ergonomics,” commented Dr. Carrozza. “The comfortable seated position allowed me to focus solely on the patient's physiology while I was able to precisely control the guidewire and stent movements, even in 1-mm increments. Our first case was successful, and I look forward to performing more procedures using CorPath.”

Jeffrey W. Moses, MD, commented, “For the very first time in my career, I was able to perform a PCI procedure without wearing a lead apron. The CorPath system's radiation-shielded cockpit provided an optimal view of the angiography screen and allowed me to easily manipulate the guidewire and accurately place the stent. I was impressed—this trial has the potential to significantly impact how we care for patients in the cath lab.”