SpineGuard announced that the third published clinical study of its FDA-cleared and CE-marked PediGuard platform for enhanced pedicle screw placement has concluded that “the use of PediGuard significantly reduced the incidence of clinically relevant misplaced screws, thereby increasing the safety of pedicle screw implantation*.” Principal investigator for the study was Dror Ovadia, Department of Pediatric Orthopaedics, Dana Children’s Hospital, Tel Aviv, Israel. The study has been published in the September 15 issue of the journal Spine.
The high incidence of misplaced pedicle screws is well-documented in the scientific literature. Indeed, misplaced pedicle screws occur in about 20% of cases, according to numerous studies published in peer-reviewed medical journals from 1987 to 2009. Clearly, this error rate is undeniable and unacceptable given the potentially dire consequences of misplaced pedicle screws—such as spinal cord damage resulting in various degrees of neurological impairment.
“The scientific literature is rife with clinical evidence that the conventional modalities for implanting pedicle screws are potentially dangerous not only to spine surgery patients but also operating room staff,” said Stéphane Bette, chief technology officer and general manager of US Operations for SpineGuard. “The PediGuard technology platform is designed to be a safe and effective alternative to conventional modalities for implanting pedicle screws. There are now more than 200 spine surgeons who have performed nearly 17,000 procedures using PediGuard.”
About the PediGuard platform
Co-invented by Maurice Bourlion, Ciaran Bolger, and Alain Vanquaethem, PediGuard is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. Nearly 17,000 procedures have been performed with PediGuard on all continents. Multicentre clinical studies of PediGuard have been published demonstrating that PediGuard doubles the pedicle breach detection rate, limits radiation exposure by 30%, and decreases by up to 10% the average time for pedicle screw placement.
* Statements made by surgeons are based upon their own experiences with the PediGuard products and may not comply with the specifics of the US FDA-approved indications for use. These statements are opinions and are provided for information only.