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SpineGuard to Launch Two New Products from Its PediGuard Platform

Mon, 10/07/2013 - 8:45am
Business Wire

SpineGuard announced today that it will launch two new products from its PediGuard platform at this week’s annual scientific meeting of the North American Spine Society (NASS), to be held in New Orleans 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 Chief Executive Officer.

“The XS Classic PediGuard penetrates bone more easily with a great tactile feel,” said PD Dr Heiko Koller, Werner Wicker Klinik, Bad Wildungen, Germany, a 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. 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,” said Sergey Neckrysh, M.D., Chief of Spine Surgery, Assistant Professor, Department of Neurosurgery, University of Illinois – Chicago.

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% (Tian 2011, Gelalis 2011, Verma 2010) with 2-7% of patients presenting neurologic complications (Amato 2010, Amiot 2000, Waschke 2012) and 4-5% of patients having vascular complications (Sarlak 2009, Samdani 2009, Belmont 2002) due to misplaced screws.

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