Corindus Vascular Robotics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its CorPath robotic system for use in peripheral vascular interventions.
The CorPath System has earlier also received FDA approval for use in percutaneous coronary intervention (PCI) and radial PCI procedures.
The approval was based on results of a robotic-assisted peripheral intervention for peripheral artery disease (RAPID) clinical study carried out at Medical University Graz in Austria.
Corindus Vascular said that the RAPID study showed that the CorPath system can be used to treat peripheral disease and previous studies have demonstrated that the system will reduce overall radiation exposure for physicians.
The study recruited 20 patients with symptomatic disease with either presence of critical limb ischemia or lifestyle-limiting claudication requiring percutaneous transluminal angioplasty.
Corindus Vascular Robotics president and CEO Mark Toland said: "Our first priority is to provide the best care to our patient community via robotic precision while protecting the physicians performing these important procedures.
"This FDA clearance demonstrates our commitment to the development of clinical data in our endeavor to expand the scope of robotic therapy."
The CorPath System is the first medical device approved by the FDA to bring robotic-assisted precision to radial coronary and peripheral procedures.
During the procedure, the interventional cardiologist will sit at a radiation-shielded workstation to advance stents and guidewires with millimeter-by-millimeter precision.
The workstation enbales the physician the freedom from wearing heavy lead protective equipment that leads to musculoskeletal injuries.