Corindus wins FDA 510(k) PVI indication for CorPath GRX

Corindus Vascular Robotics (OTC:CVRS) said today it won FDA 510(k) clearance for its CorPath GRX system, now indicated for use in peripheral vascular interventions.

The Waltham, Mass.-based company touts the CorPath system as the first and only FDA-cleared robotic device cleared for both percutaneous coronary interventions and peripheral vascular interventions.

“My colleagues and I have seen first-hand how CorPath GRX can overcome the challenges of manual PCI and I am excited to apply the capabilities of robotics to effectively treat PAD patients. As a training site for future robotic interventionalists, I look forward to teaching these techniques to further enhance the quality of care for patients with both CAD and PAD,” Dr. Alan Lumsden of Houston Methodist Hospital said in a prepared statement.

“CorPath GRX enables me to provide transformational treatment options to my patients suffering from PAD. As a long-time adopter of robotics, I am passionate about the opportunity this technology presents to advance endovascular care while providing a safer work environment for healthcare providers,” Dr. Joseph Ricotta of Tenet Healthcare and FAU said in a press release.

The newly cleared CorPath GRX system expands the uses of the system from exclusively treating coronary artery disease to include the treatment of peripheral artery disease, Corindus said.

The ability to treat patients with PAD using CorPath GRX is a significant step for Corindus as we expand the usage of our technology beyond PCI. The new indication aligns with our objective to provide more patients access to the benefits of precise robotic treatment while protecting healthcare professionals from harmful radiation during lengthy PVI procedures. We will continue to improve upon our technology platform with a keen focus on providing physicians the tools necessary to enhance patient care across the spectrum of interventional medicine,” Corindus prez & CEO Mark Toland said in prepared remarks.

Last month Corindus Vascular Robotics said it will co-sponsor training courses with medical giant Medtronic (NYSE:MDT) on transradial access techniques and robot-assisted vascular interventions, and released preliminary earnings results for its fourth quarter and fiscal year 2017.