Regulatory NewsPerspectivePublication Exclusive

First Robotic-Assisted PCI System Receives FDA Clearance

The FDA has granted 510(k) clearance to the first robotic-assisted system for the treatment of CAD.

The system (CorPath 200, Corindus Vascular Robotics) allows interventional cardiologists to perform PCI in a cockpit using two joysticks to control the catheter and devices. According to a press release, the lead-lined cockpit protects physicians from radiation, while allowing them to operate without the use of leaded aprons that can cause orthopedic issues over time. The system also has the potential to enhance the view of the angiography screen.

In the prospective, single-arm, multicenter PRECISE trial, use of the robotic-assisted system was tested in 164 patients and resulted in successful completion of PCI without having to convert to manual PCI and without device-related complications in 98.8% of patients. Overall, the procedural success rate was 97.6%, while radiation exposure of the physician was reduced by 95%. 


Joseph P. Carrozza Jr.

  • Over the years, what we’ve realized is that the cath lab is by and large an unsafe environment. So the ability to perform the procedure in a radiation-shielded cockpit without having to wear a heavy leaded apron is a huge potential advantage in terms of an operator’s safety.

    Additionally, when we do procedures in the cath lab, most of how we guide the placement of balloons and stents is through visual estimates. The robotic system actually offers us the ability to very accurately measure distances in the coronary realm — down to one-quarter of a millimeter — resulting in the ability to more accurately gauge what length of stent one needs to place and what length of balloon one needs to use. This may translate into potentially fewer stents per case since oftentimes we have to put in a second stent because the first stent is too short or long for the lesion. Also, because you’re sitting with the monitors at an ideal distance from your eyes, you actually see better with this system compared with traditional PCI.

    In terms of how this will benefit patients, first and foremost, an operator who is working in a comfortable environment and not fatigued from standing all day wearing lead is a much better operator than one who at the end of the day can barely stand up. As many interventionalist cardiologists understand, the last case of the day is often not the best case because of the fatigue factor and issues related to eye strain and wearing a lead garment.

    Although there is concern as to whether patients will accept the robotic-assisted PCI approach, ultimately I believe they will. In the clinical trial we had no trouble recruiting patients. In fact, one of the things we learned in this trial is that although it had been believed that the hands were what made interventional cardiologists great, it really isn’t; it’s their cognitive decision-making process. As you advance things like the wire, most of the time you’re making decisions as to whether or not to advance the wire based on what your eyes show, not what your hands feel, and we can actually translate very easily what we thought we were doing with our hands into the robotic system.

    • Joseph P. Carrozza Jr., MD
    • Chief, Cardiovascular Medicine
      St. Elizabeth's Medical Center, Boston
  • Disclosures: Dr. Carrozza was the principal investigator for the PRECISE trial, which was sponsored by Corindus Vascular Robotics, but reports no relevant financial disclosures.

Lloyd W. Klein

  • Robotic-assisted PCI has huge potential, in large part because there is a clear need for it in terms of improving the occupational health aspects of intervention. Beyond that, there is a lot of skepticism in the interventional cardiology community because there is a sense that the procedure could not be as precise as traditional PCI; however, if you look at what the operators are doing, it is actually quite precise. The instrument comes with a joystick and a knob: the joystick allows 1-mm movement forward and backward; the knob allows torque, with 12 turns to the full circle, or 30 degrees per turn. This is far more precision than most interventionalists are able to produce manually and this hasn’t really gotten out into the community yet. When it does, people’s mindsets are likely going to change.

    The main problem they are going to have with widespread adoption of this approach is cost. From what I’ve heard from the company, this system is looking to cost about $300,000 to start up and an additional $1,500 for disposables per case. So they are going to have to overcome both the skepticism and price. The skepticism probably won’t be hard to beat because once people give it a chance and see it in action, there is not likely going to be concern with the precision; but I do think cost is going to be a huge hurdle to overcome.

    • Lloyd W. Klein, MD
    • Professor of Medicine, Rush Medical College, Chicago
      Founding Member, Multispecialty Occupational Health Group
  • Disclosures: Dr. Klein reports no relevant financial disclosures.