“PediGuard helps me cannulate more accurately during pedicle screw placement. And, it dramatically reduces the OR’s exposure to image-guiding radiation. This is very important to us because we recently lost a partner to thyroid cancer, which we believe was radiation-induced,” Larry T. Khoo, M.D. Neurosurgeon, The Spine Clinic of Los Angeles
SAN FRANCISCO and PARIS,— SpineGuard announced today 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.
“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.”
Pedicle screw-based stabilization 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 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% (Tian 2011, Gelalis 2011, Verma 2010). The consequences of misplaced pedicle screws are not to be underestimated. Scientific literature reviews and clinical studies recently published suggest that 2.3% of patients presented neurologic complications due to misplaced screws (Gelalis 2011, Verma 2010).
Furthermore, surgeons’ greater reliance on fluoroscopy during procedures exposes the OR team to dangerous radiation: The average spine surgeon will receive the maximum allowable lifetime exposure of radiation for classified workers within 10 years of practice (Ul Haque, Shufflebarger et al, 2006);The radiation exposure in spine surgery has been found to be 10 to 12 times greater than the radiation exposure during other fluoroscopically assisted non-spinal musculoskeletal procedures (Rampersaud, 2000);The highest amount of fluoro intensity is needed for spinal procedures (Orthopedics this Week, 2010).
Co-founded in 2009 by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s 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.
About the PediGuard® platform
Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer, 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. More than 20,000 procedures have been performed with PediGuard on all continents. 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, limits radiation exposure by up to 73%, decreases by 15% the average time for pedicle screw placement and provides a 3 fold reduction in neuro-monitoring events.
SpineGuard’s mission is to make spine surgery safer. The company has offices in San Francisco and Paris. For further information, visit www.spineguard.com.