The device, originally designed for spinal surgeries, is now cleared for use in positioning surgical instruments and implants during procedures on the brain, including biopsies, shunt placements and neurostimulation electrode placement for deep brain stimulation.
The Renaissance system, which Mazor unveiled in the summer of 2011, was built on the core of the company’s previous generation SpineAssist technology.
"While our core is spine surgery, we are thrilled that our technology can be expanded to improve other surgical procedures," CEO Ori Hadomi said in prepared remarks. "As neurosurgeons focus on both the spine and brain, brain surgeries represent a large market opportunity that is closely aligned with our current focus. Achieving U.S. regulatory clearance provides us with the opportunity to assist neurosurgeons in improving brain surgery processes and the ensuing clinical outcomes."
The Israel-based company last month won Korean approval for the device, shortly after performing its 1st robot-guided brain surgeries at a hospital in Germany.