Corindus wins FDA nod for 2nd-gen CorPath GRX vascular robot-assisted surgery system

Corindus Vascular Robotics (OTC:CVRS) said yesterday that it won 510(k) clearance from the FDA for the CorPath GRX, it’s 2nd-generation vascular robot-assisted surgery platform, and plans to have it on the market during the 1st quarter of 2017.

Waltham, Mass.-based Corindus said it added several features to the latest CorPath iteration, including the ability to control the guide catheter in 1mm increments to precisely position balloon or stent catheters during percutaneous coronary interventions.

“CorPath GRX is a critical advance in our core technology and a meaningful step toward realizing our vision of fundamentally changing how PCI procedures are performed,” president & CEO Mark Toland said in prepared remarks. “GRX will enable us to build more robust and sustainable cardiovascular robotic programs with our hospital partners as we remain focused on providing the highest level of care to patients while protecting the health and wellness of the cath lab staff. We are excited to debut the GRX at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference later this week where we will be holding clinician demonstrations.”

“The new features of the next generation CorPath System, particularly the addition of active guide catheter management, will allow physicians to increase the complexity of procedures performed robotically,” added chief medical officer Dr. Aaron Grantham. “This is a tremendous advancement in the technology platform that will greatly extend the clinical capability of the system.”

In March, Corindus won 510(k) clearance from the FDA for the original CorPath system for a peripheral intervention indication, a year after launching a clinical trial.

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