The FDA has cleared the CorPath System for use during peripheral vascular interventional procedures, according to a press release issued by Corindus Vascular Robotics, Inc.
The new 510(k) clearance for peripheral intervention was based on results of the RAPID study, which evaluated the feasibility of the CorPath System 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 iliac and/or superficial femoral arteries, according to information on ClinicalTrials.gov. In this study, use of the CorPath System was associated with 100% device and clinical success, according to the release.
“For the past two years, I have been successfully treating my coronary patients with robotic precision while protecting my staff and me from the hazards of radiation exposure in the cath lab,” Ehtisham Mahmud, MD, chief of cardiovascular medicine, director of Sulpizio Cardiovascular Center-Medicine and director of interventional cardiology at UC San Diego Health System, stated in the release. “The ability to expand robotic precision to treat my peripheral disease patients is an important addition; I am looking forward to continued work with Corindus to optimize robotic therapy for peripheral procedures.”
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 for radial PCI.
Disclosure: Mahmud has served on the advisory board of and received clinical trial support from Corindus.