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(AOF) – Spineguard (+38.90% to 0.1664 euros) jumped this Tuesday after the announcement of obtaining the certification making possible the launch in Europe of its threaded PediGuard for the indication of anterior spinal surgery within the framework of the MDR (Medical Device Regulation). This French medtech is deploying its digital surgical guidance (DSG) technology to secure and simplify the placement of bone implants.
Spineguard highlights that the new Medical Device Regulation (MDR) is now applicable within the European Union and allows medical device manufacturers to be authorized to market their products there. This new regulation gradually replaces the European Medical Device Directive (MDD), “by significantly increasing the requirements for clinical benefits as well as safety and monitoring measures”.
Already widely used in various spinal indications, the threaded PediGuard sees its scope of application in Europe extended to the correction of scoliosis via the anterior approach.
Lateral placement of screws in the vertebral bodies is not without risk, as “there are neurological and vascular structures to avoid”: the Threaded PediGuard is “particularly well suited to help secure this drilling.”
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