First PediGuard™ surgery performed in Singapore

PARIS & SAN FRANCISCO - SpineVision has announced that its patented product, PediGuard™, the first and only FDA-cleared Class II device for real-time electronic detection of possible penetration outside the vertebral pedicle, has been used in Asia for the first time in a spine surgery procedure; the training of “local” spine surgeons to use PediGuard™ is now underway.

Accuracy of pedicle screw placement is an important issue in spine surgery: published rates of intraoperatively ‘misplaced’ pedicle screws range from 10 to 40 percent, some of which result 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.

“Perforating the vertebral pedicle wall is a common complication related to pedicle screw insertion, and very serious clinical consequences may result,” said Maurice Bourlion, General Manager of SpineVision Inc. and head of the Company’s PediGuard™ Division worldwide. “On the other hand, clinical studies have demonstrated that PediGuard™ enables real-time detection of potential perforation. In short, our device offers spine surgeons a simple and reliable way to detect possible vertebral cortex perforation—prior to insertion of pedicle screws. Using PediGuard™ is very straightforward. With PediGuard™, the spine surgeon remains in control at all times during drilling and, unlike conventional methods, there is no requirement for pre‧-op scans for navigational aids or continuous screening while advancing into the pedicle. Reducing the requisite number of X-rays is of course good for the patient and the OR staff as well"

“We are very pleased to report this significant milestone—the establishment of a SpineVision sales and marketing operation in Asia and the first PediGuard™ spine surgeries in Asia—as it underscores the dramatic progress we are making in establishing PediGuard™ as the standard of care for alerting surgeons to potential pedicular or vertebral breaches during pedicle screw site preparation,” said Julian Mackenzie, CEO of SpineVision. “We are also very pleased that Alvin Loh is managing our PediGuard™ sales in Southeast Asia. He is a very successful sales-and-marketing executive with tremendous experience in the Southeast Asia device market in general and Singapore in particular,” added Mr. Mackenzie. “We expect him to have an immediate impact in Singapore calling on orthopedic surgeons and neurosurgeons who treat spine disorders, and then expand SpineVision’s presence throughout the Southeast Asia territory, including the Philippines, Malaysia, Thailand and Indonesia. We believe that our PediGuard™ product, which has tremendous potential because it provides a compelling solution to one of the most difficult challenges in spine surgery, will open a lot of doors right off for Alvin and his team.”