Mar 30 2016
Corindus Vascular Robotics, Inc., a leading developer of precision vascular robotics, announced today that the U.S. Food and Drug Administration has cleared the CorPath® System for use in peripheral vascular interventions.
This is the third clearance for the CorPath System including the initial clearance for percutaneous coronary intervention (PCI) which was followed by a clearance for radial PCI in October 2015. This 510(k) clearance for peripheral intervention was based on results of a clinical trial known as the RAPID (Robotic-assisted Peripheral Intervention for Peripheral Artery Disease) Study conducted at Medical University Graz in Austria.
"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."
Peripheral vascular procedures can be lengthy and lead to a very high level of radiation exposure for the physicians performing these procedures. The RAPID Study demonstrated that the CorPath System can successfully be used to treat peripheral disease, and previous studies have shown that using the CorPath System will reduce overall radiation exposure for physicians.
"Our first priority is to provide the best care to our patient community via robotic precision while protecting the physicians performing these important procedures," said Mark Toland, President and CEO, Corindus. "This FDA clearance demonstrates our commitment to the development of clinical data in our endeavor to expand the scope of robotic therapy."
The RAPID Study enrolled 20 patients with symptomatic disease with either presence of critical limb ischemia or lifestyle-limiting claudication requiring percutaneous transluminal angioplasty. The CorPath System demonstrated 100% device and clinical success in the study.