SpineGuard has announced that the 20,000th case has been performed using its family of PediGuard devices for enhanced pedicle screw placement. The PediGuard product line includes Cannulated PediGuard, Curved PediGuard, and Classic PediGuard.
Co-founded in 2009 by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s stated primary objective is to establish its FDA-cleared and CE Marked PediGuard® device as the global standard of care for safer pedicle screw placement in spine surgery.
PediGuard is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches, real-time feedback being provided via audio and visual signals. More than 20,000 procedures have been performed with PediGuard on all continents.
Pedicle screw-based stabilisation has become the gold standard for treating spine instabilities and deformities. This market is growing 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 stabilisation and thoracic screws place further emphasis on 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 analysis suggested the average rate of misplaced screws to be approximately 20%. The consequences of misplaced pedicle screws reportedly include neurologic complications which have been quoted to occur in 2.3% of patients.
Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard presents an accuracy rate of 97%, doubles the pedicle breach detection rate, decreases by 15% the average time for pedicle screw placement and provides a threefold reduction in neuro-monitoring events.
Furthermore, surgeons’ greater reliance on fluoroscopy during procedures exposes the OR team to dangerous radiation due in no small part to the high fluoro intensity required for spinal procedures. The fact that PediGuard has been found to reduce radiation exposure by as much as 73% is therefore a welcome feature.
“PediGuard has evolved into a standard-of-care device in our spine surgery practice,” said Larry T. Khoo, M.D., Neurosurgeon, The Spine Clinic of Los Angeles. “Not only is PediGuard designed to facilitate safer pedicle screw insertion, but also PediGuard makes spine surgery safer for the OR staff by reducing our dependence on fluoroscopy (a type of X-ray commonly used by physicians to obtain real-time images of the spine during surgery). Our own studies have shown that the use of PediGuard reduces fluoroscopy time by up to one-third in some surgeons’ cases. This benefit is very important to us, as we recently lost a partner to a highly malignant thyroid tumor that we strongly believe was radiation-induced.”
“Worldwide PediGuard sales are steadily increasing because the safe placement of pedicle screws continues to be a major challenge in spine surgery and OR teams are more and more aware of the dangers associated with the excessive use of fluoroscopy,” said Pierre Jérôme, CEO of SpineGuard. “No doubt, with 20,000 spine procedures now having been performed across 40 countries and the growing clinical evidence published in peer-reviewed medical journals, PediGuard is emerging as a compelling solution to the challenges associated with pedicle screw placement.”
“Several published studies have substantiated the value proposition of PediGuard for spine professionals and their patients: pedicle breach anticipation, plus reduction of radiation exposure and surgery time,” added Stéphane Bette, Chief Technology Officer and General Manager of U.S. Operations for SpineGuard. “Another reason for our ramp-up is our aggressive new-product development blueprint with most recently the launch of the Cannulated PediGuard.”
Source: SpineGuard, Business Wire