SpineGuard has announced that it has received regulatory approval from the Roszdravnadzor, the Russian healthcare agency that oversees medical devices, to market its PediGuard system in Russia and is partnering with Moscow-based Multi-Systems Technology (“MST”) to sell PediGuard in Russia.
According to a SpineGuard press release, MST has an extensive network of 53 distributors across Russia—from Kaliningrad in the west across seven time zones to Khabarovsk in the Russian Far East. MST specialises in products for neurosurgery, spine surgery, trauma and orthopaedics.
“This regulatory clearance is the result of a very effective collaboration with MST, which is promising for the adoption of Pediguard in Russia,” said Pierre Jérôme, co-founder and chief executive officer of SpineGuard. “I am of course delighted that Russian spinal 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.”
Pediguard has been used in more than 24,000 procedures in over 40 countries. The press released stated that there are approximately 300 spinal surgeons, who are now using Pediguard on a regular basis.