SpineGuard Receives FDA Clearance for Mini Version of PediGuard
SpineGuard has received 510(k) clearance from the U.S. Food andDrug Administration for three new products that complete its PediGuard platform of single-use drilling instruments which secure the pedicle screw pilot hole: Two miniaturized versions of its classic and curved range, and a directional version of its cannulated series.
“This new product-development milestone now empowers SpineGuard to assist surgeons in the most challenging clinical situations in spine, and fortifies our technology in the U.S. market,” co-founder/ CEO Pierre Jérôme 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,” added co-founder/Chief Technology Officer Stephane Bette.
Pedicle screw-based stabilization has become the gold standard for treating spine instabilities and deformities, according to the company. The market is expanding due to the increasing number of patients requiring surgical treatment and a larger number of surgeons being trained in pedicle screw-based technologies. Technological advancements such as minimally invasive surgery, bone substitutes, dynamic stabilization and thoracic screws further reiterate the importance of pedicle screw placement.
However, accuracy of pedicle screw placement remains a critical issue in spine surgery. In recently published papers studying screw placement accuracy, the average rate of misplaced screws is approximately 20 percent (Tian 2011, Gelalis 2011, Verma 2010) with 2 percent to 7 percent of patients presenting neurologic complications (Amato 2010, Amiot 2000, Waschke 2012) and 4 percent to 5 percent of patients having vascular complications (Sarlak 2009, Samdani 2009, Belmont 2002) due to misplaced screws.
Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, biomedical engineer, PediGuard is a handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. More than 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 percent of pedicle breaches, presents an average screw placement accuracy of 97 percent (vs. 92 percent on average for navigation), provides three-fold less pedicle perforations than with free-hand technique and a three-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25 percent to 30 percent and decreases the time for pedicle screw placement by 15 percent.
Founded in 2009, SpineGuard has offices inSan Francisco,Calif., and Paris, France. The company has been listed on the New York Stock Exchange since April 29.