The U.S. Food and Drug Administration approved Corindus Vascular Robotics Inc.'s CorPath GRX system for artery surgeries on limbs.
CorPath GRX allows surgeons perform minimally invasive procedures using a robotic operating device, controlled from a radiation-shielded workstation. The device inserts a catheter into a patient's blood vessel, making its way to clear a blocked artery. Surgeons would typically cut above the affected area to clear or bypass blockages.
The FDA clearance expands the platform's use to include peripheral artery disease, in which a patient's narrowed arteries reduce blood flow to the arms and legs.
Waltham, Mass.-based Corindus said there was an estimated $3.4 billion market for peripheral procedures in 2017. An estimated 8.5 million people in the U.S. have peripheral artery disease.
CorPath GRX was already granted 510(k) clearance for coronary artery disease, in which plaque builds up in the arteries that supply blood to the heart.