A handheld device that can warn surgeons of potential spinal breaches, used in 10,000 patients worldwide, will shortly become available in the UK.
US specialist SpineGuard has formed an agreement with MBA, a leading marketer and distributor of orthopaedic devices, to distribute its PediGuard device exclusively in Italy, Portugal, Spain and the UK.
PediGuard, which has CE Mark approval, is designed to increase the safety of pedicle screw placement in spinal surgery.
Nearly one million spine procedures using pedicle screws were performed in 2009. There is a significant risk of pedicle screw misplacement, which can lead to serious complications and expose hospitals to litigation.
PediGuard is the only handheld device that alerts surgeons to potential pedicular or vertebral breaches. Clinical studies have demonstrated that PediGuard doubles the rate of pedicle breach detection.
Pierre Jérôme, CEO of SpineGuard, said: "MBA has built a robust sales and marketing organisation over the years, and they have strong credibility among spine surgeons. I have been particularly impressed by the quality of MBA's management team and by their state-of-the-art training facilities. I look forward to a fruitful collaboration between SpineGuard and MBA and seeing PediGuard become a standard of care for pedicle screw placement in the UK, Spain, Portugal and Italy."
"MBA is delighted that SpineGuard has chosen our organisation as its marketing and distribution partner for these territories," commented Paul Griffin, MBA's Chief Operating Officer. "This exciting and highly innovative technology has the potential to significantly reduce serious complications in patients undergoing major spine surgery.
"SpineGuard has state-of-the-art technology and MBA has the resources to bring this exceptional product quickly and successfully into regular use in some of the principal and most competitive markets outside the US."
PediGuard