SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for three new products, designed to enhance pedicle screw penetration of small and/or difficult-to-access pedicles.
The two miniaturized versions of its classic and curved range, and a directional version of its cannulated series completes the PediGuard platform of single-use drilling instruments which secure the pedicle screw pilot hole.
SpineGuard co-founder and CEO Pierre Jérôme noted this new product-development milestone now empowers SpineGuard to assist surgeons in the most challenging clinical situations in spine, and fortifies our potentially game-changing technology in the US market.
SpineGuard co-founder and chief technology officer Stephane Bette said, "The addition of a miniaturized PediGuard sensor opens the door to multiple new potential small-size applications of our platform, such as drill bits, guide wires or implants."
The accuracy of pedicle screw placement remains a critical issue in spinal surgery irrespective of much technological advancement.
Data from recently published papers studying screw placement accuracy show that the average rate of misplaced screws is approximately 20% (Tian 2011, Gelalis 2011, Verma 2010) with 2-7% of patients presenting neurologic complications (Amato 2010, Amiot 2000, Waschke 2012) and 4-5% of patients had vascular complications (Sarlak 2009, Samdani 2009, Belmont 2002) due to misplaced screws.
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.