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SpineGuard secures FDA clearance for three new Pediguard products

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.