FDA Clears Corindus CorPath Robotic System for Use in Peripheral Vascular Interventions

March 29, 2016—Corindus Vascular Robotics, Inc. announced that the US Food and Drug Administration has cleared the company’s CorPath system for use in peripheral vascular interventions. The CorPath system was initially cleared for percutaneous coronary intervention (PCI), which was followed by a clearance for radial PCI in October 2015. 

The 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. The study demonstrated that the CorPath can be used to treat peripheral disease, and previous studies have shown that using the CorPath system will reduce overall radiation exposure for physicians, noted Corindus in its announcement. RAPID 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.

During procedures using CorPath, the interventionist is situated at a radiation-shielded workstation, which aims to serve the dual purpose of limiting operator exposure to radiation as well as musculoskeletal issues related to wearing lead. Robotic assistance is also designed to enhance operator control of incremental device advancement. 

In Corindus’ press release, Ehtisham Mahmud, MD, commented, “For the past 2 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. 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.” Dr. Mahmud is Chief of Cardiovascular Medicine, Director of Sulpizio Cardiovascular Center-Medicine, and Director of Interventional Cardiology at UC San Diego Health System in San Diego, California.