FDA Clears Miniaturized, Directional Versions of SpineGuard’s PediGuard® Platform

SpineGuard has received FDA 510(k) clearance of three new products that complete its PediGuard platform of single-use drilling instruments, designed to make pedicle screw pilot hole placement safer and more accurate. Now approved are two miniaturized versions of its classic and curved range, and a directional version of its cannulated series.

Background

Pedicle screw-based stabilization has become and remains in most eyes the gold standard for treating spine instabilities and deformities. An increasing number of patients require surgical treatment and an ever-larger number of surgeons are being trained in pedicle screw-based technologies.

Technological advancements such as minimally invasive surgery, bone substitutes, dynamic stabilization and thoracic screws mean accuracy of pedicle screw placement under different circumstances remains a critical issue. In its press release, SpineGuard draws our attention to the fact that recently published papers studying screw placement accuracy show the average rate of misplaced screws to be 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 having vascular complications (Sarlak 2009, Samdani 2009, Belmont 2002) due to misplaced screws.

Unsurprisingly Spineguard claims to have the solution in the form of its PediGuard® Platform, claimed to be the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches with real-time audio and visual feedback.

Over 27,000 procedures have been performed with PediGuard on all continents. Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98% of pedicle breaches, presents an average screw placement accuracy of 97% (vs. 92% on average for navigation), provides 3-fold less pedicle perforations than with free-hand technique and a 3-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25-30% and decreases by 15% the time for pedicle screw placement.

Company comments

 

“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,” said Pierre Jérôme, co-founder and Chief Executive Officer. “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,” added Stephane Bette, co-founder and CTO.

Source: SpineGuard SA.