Corindus asks FDA for expanded neurosurgery indication for CorPath GRX

Corindus Vascular Robotics (OTC:CVRS) said today that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions. The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions, which it won in 2016, and for peripheral vascular interventions, which it won last year. “The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics. Applying the benefits of robotic precision to neurovascular intervention, while building a wealth of clinical knowledge and expertise, are key to preparing for a future of remote stroke treatment,” chief medical officer Dr. Aquilla Turk said in a prepared release. Corindus touted that if it receives the clearance, the CorPath GRX system would be the world’s first and only robotic platform indicated for all three indications. “An expansion of CorPath GRX to treat neurovascular conditions would represent a major stepping stone towards our goal of revolutionizing stroke treatment. We believe that our current robotic platform will bring benefits to neurovascular procedures today and we will leverage our recent achievements in telerobotics and strong focus on technology development to build a remote stroke solution to tackle the challenge of access to care. This would extend the reach of highly-skilled specialists across the globe by g...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance Robotics Surgical Corindus Vascular Robotics Source Type: news