Corindus Vascular Robotics is seeking premarket clearance from the US Food and Drug Administration (FDA) to use the CorPath GRX System in neurovascular intervention.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
CorPath GRX, the second generation robotic platform, received FDA clearance for percutaneous coronary intervention (PCI) in 2016 and peripheral vascular intervention (PVI) in 2018. Upon successful FDA clearance, CorPath GRX would become the world’s first and only robotic platform indicated for use in PCI, PVI and neurovascular intervention (NVI).
“An expansion of CorPath GRX to treat neurovascular conditions would represent a major stepping stone towards our goal of revolutionizing stroke treatment,” said Mark Toland, President and Chief Executive Officer of Corindus.
“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 granting remote access to patients suffering from life-altering diseases where access to care is limited and time to treatment is paramount,” added Toland.
Corindus established a Physician Steering Committee dedicated to the Neuroendovascular sector last year and appointed Dr. Aquilla Turk as the Company’s chief medical officer. Dr. Turk and the steering committee are tasked with spearheading the Company’s clinical initiatives, including establishing dedicated neurovascular programs to expand robotic treatment, extending the advanced robotic capabilities across the spectrum of vascular interventions.
“The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics,” said Dr. Turk. “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.”
This announcement comes on the heels of Corindus’ announcement that its technology was successfully used to conduct the first-in-human Telerobotic Intervention Study. The study was the world’s first-in-human PCI conducted from a remote location approximately 20 miles outside of the catheterization lab and solidifies Corindus’ commitment to providing better patient care to underserved patient populations with geographic barriers to treatment.
Source: Company Press Release