SpineGuard to Launch Two New Products at NASS

SpineGuard S.A., a Paris, France-based company with U.S. headquarters in San Francisco, Calif., will be launching two new products from its Pediguard platform at the North American Spine Society (NASS) annual meeting in New Orleans, La., on Oct. 9-12.

The new products, XS Classic Pediguard and XS Curved Pediguard, expand the company’s platform of single-use drilling instruments that are designed to secure a pedicle screw pilot hole for optimal placement by spine surgeons.

“The expansion of the Pediguard platform is an integral part of our company’s mission to help surgeons meet the highest safety standards for the most challenging clinical situations in spine,” said Pierre Jérôme, co-founder and CEO of SpineGuard.

Pediguard is a handheld device intended to alert surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. According to SpineGuard, studies have shown the device to detect 98 percent of pedicle breaches, have an average screw placement accuracy of 97 percent, provide three times less pedicle perforations than with a free-hand technique and a three-fold reduction in neuro-monitoring alarms. The device is also reported to limit radiation exposure by 25-30 percent and decreases the time for pedicle screw placement by 15 percent.

“The XS Classic Pediguard penetrates bone more easily with a great tactile feel,” said Heiko Koller, P.D., reviewer for European Spine Journal and Spine. “This new feature of the XS Classic Pediguard allows for easier access to the intended cervical pedicle direction, particularly in patients with challenging cervical anatomy and deformities.”

“The new miniaturized sensor of the XS Curved Pediguard allows us to access the smallest and most difficult pedicles encountered in our deformity cases,” said Sergey Neckrysh, M.D., chief of spine surgery and assistant professor in the University of Illinois – Chicago’s department of neurosurgery. “Like for the precedent design, the new curve gives us precious directional information as well as the ability to redirect. In a teaching context, it is very reassuring to receive the instant auditory feedback when the resident or any other trainee is creating the trajectory for the screw within the pedicle.”

Pedicle screw-based stabilization is the gold standard for treating spine instabilities and deformities. This market is growing due to an 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 percent with 2-7 percent of patients presenting neurologic complications and 4-5 percent of patients having vascular complications due to misplaced screws.

Pediguard has the CE mark for commercialization in the European Union, and is cleared by the U.S. Food and Drug Administration.

Editor’s note: SpineGuard will be exhibiting its Spineguard portfolio and more at booth no. 2539 during the NASS meeting.