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Robotic System Cleared for Use in Peripheral Vascular Interventions
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The use of robotics may now be used for peripheral vascular interventions, after the FDA in March cleared the CorPath Vascular Robotic System for this new indication.
The 510(k) clearance for peripheral vascular intervention was based on results of the RAPID study, which evaluated the feasibility of the CorPath system (Corindus Vascular Robotics) to deliver guidewires and balloons to blockages in non-coronary arteries. Researchers at Medical University Graz in Austria enrolled 20 patients with symptomatic disease, including the presence of critical limb ischemia or lifestyle-limiting claudication requiring intervention in the iliac and/or superficial femoral arteries. In the RAPID study, use of the CorPath System was associated with 100% device and clinical success, according to a company press release.
The CorPath Vascular Robotic System enables robotic-assisted control of guidewires and balloon or stent devices during interventional procedures from the safety of a radiation-protected cockpit and without the need for wearing heavy lead protection. The system consists of a bedside unit and an interventional cockpit, which features a console with joysticks and touchscreen controls that enable precise control of the movement of guidewires and balloon or stent catheters and measurement of anatomy length. The bedside unit services as the “engine” of the system, by translating commands into movement and manipulations, according to the company website.
In an interview with Cardiology Today’s Intervention, Paul T. Campbell, MD, a cardiologist at Sanger Heart and Vascular Institute in Concord, North Carolina, said he has been using the CorPath Vascular Robotic System for about 2 years.
Paul T. Campbell
According to Campbell, technology such as this is “the future” of medicine. “The key to the whole system is that it gives you precision, it gives you control and it gives you safety,” he told Cardiology Today’s Intervention.
This marks the third FDA clearance for the CorPath System. The initial clearance was for use during PCI and the second clearance was for use during radial PCI.
“The ability to expand robotic precision to treat my peripheral disease patients is an important addition,” Ehtisham Mahmud, MD, chief of cardiovascular medicine, director of the Sulpizio Cardiovascular Center-Medicine and director of interventional cardiology at UC San Diego Health System, stated in the release.
Campbell noted that many peripheral vascular interventions can be “long and complex.” He said the new peripheral indication is key because it will aid in “not only precision and control, but the benefit of being able to sit and have better visualization and do more cases.”
- For more information:
- Corindus Vascular Robotics. www.corindus.com
- Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease (RAPID). Clinicaltrials.gov/ct2/show/NCT02371785. Accessed on April 29, 2016.
Disclosure: Campbell reports no relevant financial disclosures. Mahmud has served on the advisory board of and received clinical trial support from Corindus.