New Robotic System Receives FDA Clearance for Peripheral Vascular Interventions
Corindus Vascular Robotics got US Food and Drug Association (FDA) clearance for CorPath System to be used in peripheral vascular interventions. With this it became the third FDA clearance for CorPath System following percutaneous coronary intervention (PCI) and radical PCI.
CorPath Robotic System works by facilitating precise, robotic assisted regulation of coronary guide wires, balloon/stent and other devices used during percutaneous coronary intervention in a radiation controlled environment. Below video explains how CorPath robotic angioplasty works (Courtesy: Corindus Vascular Robotics)
The 510(k) clearance was based on RAPID (Robotic assisted Peripheral Intervention for Peripheral Artery Diseases) clinical trial study conducted at Medical University Graz, Austria for the treatment of peripheral diseases. It involved 20 patients suffering from either critical limb ischemia or with lifestyle limiting claudication requiring percutaneous transluminal angioplasty in which the CorPath system exhibited 100% device and clinical study success. The previous studies of the CorPath system had demonstrated reduction in overall radiation exposure for physicians compared to other peripheral vascular procedures which could be lengthy and could lead to the danger of a very high level of radiation exposure for the physicians.
“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,” said Ehtisham Mahmud, Chief of Cardiovascular Medicine, Director of Sulpizio Cardiovascular Center-Medicine, and Director of Interventional Cardiology at UC San Diego Health System. “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.”