CorPath GRX robotic system receives FDA 510(k) clearance


Corindus Vascular Robotics has received 510(k) clearance from the FDA for its CorPath GRX, the second generation of its CorPath vascular robotic system. A press release states that 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. The company expects to commence commercialisation of the new system in the first quarter of 2017.

According to the press release, the new features of the system include Active Guide Management that enables control of the guide catheter along with robotic control of the guidewire and balloon or stent catheter, with 1mm advancement, from the control console. This precise positioning will enable physicians to adjust guide catheter position during percutaneous coronary intervention (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.

Mark Toland, president and chief executive officer of Corindus, comments: “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. 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 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA), where we will be holding clinician demonstrations.”