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SpineGuard obtains regulatory clearance to sell its PediGuard platform in Japan

SpineGuard, a developer of handheld surgical device for spine surgery, has obtained regulatory Ninsho approval to sell its PediGuard platform in Japan.

PediGuard is reportedly the only handheld device that is capable of alerting surgeons to potential pedicular or vertebral breaches. It also provides real-time feedback through audio and visual signals.

SpineGuard co-founder and CEO Pierre Jerome noted this regulatory clearance is the result of a diligent collaborative process with the company’s Japanese partners, notably Surgical Spine, who played an instrumental role in this achievement and will be launching PediGuard at the Nagoya Spine Meeting later this week.

"We are extremely pleased to now be able to offer Japanese spine surgeons and their patients the significant safety benefits that result from using PediGuard devices, whose value in boosting the accuracy of pedicle screw placement has been unequivocally validated in several peer-reviewed medical journals," Jerome added.

The accuracy of pedicle screw placement remains a critical issue in spinal surgery irrespective of much technological advancement.

The PediGuard device, which has been co-invented by Dr Maurice Bourlion, Dr Ciaran Bolger and biomedical engineer Alain Vanquaethem, reduces radiation exposure by 25-30% and the time taken for pedicle screw placement by 15%.

PediGuard detects 98% of pedicle breaches, presents an average screw placement accuracy of 97%, provides three-fold less pedicle perforations than with free-hand technique and a three-fold reduction in neuro-monitoring alarms, according to studies published in peer-reviewed medical journals.