Roszdravnadzor, the Russian healthcare agency, has granted regulatory approval to SpineGuard's handheld, wireless device PediGuard.
Available as classic, curved and cannulated designs, PediGuard detects possible vertebral cortex perforation during pedicle preparation for screw placement and alerts the surgeon prior to a breach by accurately analyzing the electrical conductivity of the surrounding tissues in real time.
To expand the availability of PediGuard, SpineGuard has collaborated with Moscow-based Multi-Systems Technology (MST) to sell the device in Russia.
SpineGuard co-founder and chief executive officer Pierre Jerome said the regulatory clearance is the result of an effective collaboration with MST.
"I am of course delighted that Russian spine surgeons and their patients can now benefit from PediGuard, whose value in pedicle screw placement accuracy has been dramatically demonstrated in several peer-reviewed medical journals," Jerome added.
