SpineGuard (FR0011464452 – ALSGD) recently announced that it will launch its next-generation PediGuard “Threaded” device enabled by DSG (Dynamic Surgical Guidance) technology at next week’s 31stannual meeting of the North American Spine Society (NASS) in Boston on October 26-29.
The innovative PediGuard Threaded device with DSG is a drilling instrument with a threaded shaft design available in various sizes. It may be used to streamline surgical steps while maintaining the accuracy of pedicle preparation for screw placement. Additionally, it may reduce the use of intraoperative imaging in standard and MIS procedures.
“The PediGuard Threaded device is a transformative product in spine surgery. It combines the need to make a pilot hole and do a tap into one-step. As it is threaded, surgeons can get a very nice controlled advancement of the tip down through the pedicle, which gives steady feedback regarding the positioning of the pedicle screw pilot hole,” said Ciaran Bolger, MD, PhD, Professor of Clinical Neuroscience, Beaumont Hospital, Dublin, Ireland.
“Because we can be confident in our guided placement, we have been able to reduce the amount of fluoroscopy used during minimally invasive procedures. I estimate that, at our spine center, we have reduced the number of fluoroscopy images by about 50%,” said Larry T. Khoo, MD, The Spine Clinic of Los Angeles, California. “My practice is 90-100% minimally invasive, so I routinely use the PediGuard Threaded device in the vast majority of my cases. I use it in everything from routine lumbar to thoracic screw cannulations.”
“I have used the PediGuard Threaded device for CBT (cortical bone trajectory),” added Richard A. Hynes, MD, FACS, President of The B.A.C.K. Center in Melbourne, Florida. “Due to the significant cortical bone in this pedicle screw method, tapping of the bone is recommended. With the PediGuard Threaded device, I am able to benefit from a prospective warning of breaching the bone while performing the tapping step simultaneously. This may result in improved safety, efficiency and accuracy while consistently facilitating the longest possible screw lengths.”
Stéphane Bette, CTO and Co-Founder of SpineGuard, concluded, “Learning now on 50,000 surgeries secured with DSG™ technology, SpineGuard continues to enhance the value offered to surgeons and hospitals with the US launch of our new, finely designed PediGuard Threaded range, further demonstrating how our DSG technology can be integrated within pedicle screw instrumentation for additional clinical benefits and efficiencies.”
SpineGuard reports 50,000 spine procedures performed using its family of PediGuard devices for accurate pedicle screw placement. The PediGuard product line includes the PediGuard Straight, PediGuard Curved, PediGuard Cannulated, and now, PediGuard Threaded.
The DSG screw was presented in a symposium on October 5 at the EUROSPINE Annual meeting in Berlin, Germany. The US-FDA clearance is progressing well with the company submission of the 510k on October 14.
Latest news release: SpineGuard reports €1.7M revenue for 3Q 2016, and 9 months growth of 15%
Next financial press release: 2016 full year revenue, January 5, 2017
SpineGuard will participate at Actionaria retail investor show on November 18 and 19 in Paris.