Robot-assisted PCI system gets 510(k) clearance from the FDA

July 25, 2012

Bethesda, MD - The US Food and Drug Administration (FDA) has granted 510(k) clearance for a new remote-control robotically assisted system to be used in PCI procedures[1]. Use of the system, known as the CorPath 200 (Corindus Vascular Robotics, Natick, MA), has previously been reported to be technically feasible in the treatment of patients with coronary artery disease, with no occurrences of major adverse cardiac events at 30 days. Most important, use of the robotic remote-control system resulted in a significant reduction in operator exposure to radiation.

The system consists of an articulating robotic arm attached to the cath-lab patient table. Rather than standing bedside the patient table as in conventional PCI, the operator is located within a shielded interventional cockpit with a touch screen and joystick controls used to move and manipulate the PCI devices.

In the Percutaneous Robotically Enhanced Coronary Intervention Study (PRECISE), which was led by Dr Giora Weisz (New York Presbyterian Hospital/Columbia University Medical Center, New York) and Dr Joseph Carrozza (St Elizabeth's Medical Center, Boston, MA), researchers performed PCI in 98.8% of patients without conversion to manual PCI and without complications. Importantly, use of the system reduced exposure to radiation 95% compared with conventional PCI. Dr Juan Granada (Cardiovascular Research Foundation, Orangeburg, NY), who was involved in a study testing the device, previously told heartwire that researchers expect the system to be helpful in long procedures with complex patients.

The occupational hazards of performing long PCI and electrophysiology procedures while wearing a lead vest are well documented. In addition to spine problems, the exposure to radiation increases the risk of developing cataracts and, possibly, brain cancer. Earlier this year at the Society for Cardiovascular Angiography and Intervention (SCAI), Weisz told heart wire that be believes the robotic system will standardize PCI procedures and allow stents to be placed more accurately.

There are remote-control systems already used for electrophysiology procedures, including the Artisan Control Catheter/Sensei Robotic Catheter System (Hansen Medical, Mountain View, CA), which has been used in the ablation of atrial fibrillation, and the Stereotaxis Magnetic Navigation System (Stereotaxis, St Louis, MO). In interventional cardiology, one study, reported by heart wire , showed that operators could use the Stereotaxis system to advance and position guidewires across difficult-to-treat coronary lesions.

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