SpineVision Receives FDA Clearance for PediGuard surgical drill

22 February 2005

SpineVision(R) announced today that it has received from the U.S. Food and Drug Administration (FDA) clearance to market the Company's PediGuard(TM) instrument as an FDA Class II device. This is the first and only FDA-cleared device for real-time detection of possible penetration outside the vertebral pedicle.

PediGuard is a drilling instrument that constantly monitors the electrical conductivity of the tissue at its tip throughout the drilling process. PediGuard measures and translates the electrical conductivity into an audio and visual feedback. Its sensitivity allows the surgeon to know whether the tip is in contact with cortical bone, cancellous bone, soft tissues or blood. The surgeon is immediately informed through variations of sound cadence, sound pitch and LED flashes, when and if the electrical conductivity at the distal part of the instrument changes--thus helping the surgeon to better control the surgical procedure.

Accuracy of pedicle screw placement is still an issue in spine surgery. Indeed, published rates of intraoperatively 'misplaced' pedicle screws range from 10 to 40 percent. Of that number, 2 to 10 percent have resulted in pathological consequences such as spinal cord damage, including paraplegia or quadriplegia. Consequently, liability risks for spine surgeons are high. PediGuard is the first patented, wireless, handheld instrument capable of accurately detecting changes in tissue type, thus alerting surgeons to potential pedicular or vertebral breaches during pedicle screw site preparation. Real-time feedback is provided to surgeons via audio and visual signals, giving them new additional information. The use of PediGuard requires no change in surgical technique.

As part of the FDA clearance process, a successful multi-center study involving PediGuard was completed. The results of this study were published in European Spine Journal, 12(1), 2003.

"Perforation of the vertebral pedicle wall is a well-known complication related to pedicle screw insertion. Very serious clinical consequences --from paresthesia, partial leg paralysis to complete paraplegia -- may result," said Randal R. Betz, M.D., Chief of Staff at Shriners Hospitals for Children, and Medical Director of Shriners' Spinal Cord Unit. "Clinical studies have demonstrated that the PediGuard technology allows real-time detection of possible perforation through electrical conductivity variation," added Dr. Betz. "In short, this device offers spine surgeons a means to detect possible vertebral cortex perforation--prior to insertion of pedicle screws," concluded Dr. Betz.

"The patented technology that makes PediGuard unique is very straightforward, and the amount of time spine surgeons need in order to feel confident in using PediGuard as a navigational tool is quite brief," said Professor Ciaran Bolger, an internationally renowned expert in image-guided surgery and Head of the Clinical Neuroscience Department at the Royal College of Surgeons in Ireland. "With PediGuard, the spine surgeon remains in control at all times during drilling and, unlike traditional methods, there is no requirement for preoperative scans for navigational aids or continuous screening when advancing into the pedicle. Reducing the required amount of X-rays is both beneficial to the patient and the OR staff," said Professor Bolger, who developed PediGuard in collaboration with SpineVision's R&D team.

"We are extremely pleased with this FDA clearance for PediGuard," added Gerard Vanacker, chief executive officer of SpineVision(R). "Because our PediGuard device overcomes the great challenge of pedicle screw placement, we strongly believe that PediGuard can become a key tool to assist surgeons. The clinical experience exceeded our expectations in terms of product performance and acceptance by the surgeons. This is the first of many innovative products that we expect to bring to market in the United States."

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