Corindus Vascular Robotics (CVRS) Reports FDA Clearance for Next-Gen Robotic System

October 27, 2016 5:55 PM EDT

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Corindus Vascular Robotics, Inc. (NYSE MKT: CVRS), a leading developer of precision vascular robotics, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CorPath GRX, the second generation of its CorPath Vascular Robotic System. Corindus expects to commence commercialization of CorPath GRX in the first quarter of 2017.

“CorPath GRX is a critical advancement in our core technology and a meaningful step toward realizing our vision of fundamentally changing how PCI procedures are performed,” said Mark Toland, President and CEO of Corindus. "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."

CorPath GRX significantly builds upon the CorPath platform, adding a significant number of key upgrades that increase precision, improve workflow, and extend the capabilities and range of procedures that can be performed robotically. These features include Active Guide Management which enables control of the guide catheter along with robotic control of the guidewire and balloon or stent catheter, with one-millimeter advancement, from the control console. This precise positioning will enable physicians to adjust guide catheter position during PCI procedures, and may expand use of CorPath to more complex cases. CorPath GRX also features a completely redesigned Bedside Unit featuring an Extended Reach Arm and a touchscreen display to streamline workflow.

"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,” said J. Aaron Grantham, M.D., Chief Medical Officer of Corindus. “This is a tremendous advancement in the technology platform that will greatly extend the clinical capability of the system."

Corindus' CorPath System is the first and only FDA-cleared medical device to bring robotic precision to Percutaneous Coronary Interventions (PCI) and protects medical professionals from radiation exposure occurring in hospital cath labs.

CorPath GRX will be on display for the first time at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference where Corindus will sponsor a breakfast symposium entitled "Robotic Therapy – Current Applications & Future Vision" on Monday, October 31 at 7:00 a.m. Register here to visit Corindus at Booth #1322 for an opportunity to use CorPath GRX with an advanced simulator.



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