SpineGuard is expanding its Dynamic Surgical Guidance platform for enhanced pedicle screw placement by introducing the Bevel-Tip Cannulated PediGuard at the occasion of the WCMISST (World Congress of Minimally Invasive Spine Surgery and Techniques) taking place at the time of writing in Paris.
Background
Now well-established, minimally invasive spine surgery has the advantage of less disruption to the muscles while treating disorders of the spine. This in turn can result in decreased operative blood loss and reduced soft tissue destruction, allowing quicker recovery and faster patient return to normal function.
MIS pedicle screw placement brings its own challenges however, requiring greater reliance on tactile feel, coupled with massive use of fluoroscopy with its associated considerable amount of radiation.
SpineGuard points out that its cannulated PediGuard expands the applicability of pedicle screw placement with real-time feedback by allowing spine surgeons to benefit from the PediGuard Dynamic Surgical Guidance technology in the small, confined spaces of MIS. Search our pages for a number of articles on the development of the technology over recent years.
PediGuard is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. Over 30,000 procedures have been performed with PediGuard on all continents.
Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98% of pedicle breaches, presents an average screw placement accuracy of 97% (vs. 92% on average for navigation), provides 3-fold less pedicle perforations than with free-hand technique and a 3-fold reduction in neuro-monitoring alarms.
It also limits radiation exposure by 25-30% and decreases by 15% the time for pedicle screw placement.
Now the company is adding to its Pediguard range with the addition of the bevel-tip iteration which should further enhance accuracy of tip position as explained below.
Physician comments
“The bevel-tip is a much needed addition to the Cannulated PediGuard product offering. In my experience, using needles with such a tip minimizes “skiving” of the needle at the pedicle entry point and helps me steer the needle as I am advancing down a pedicle. This tip and the PediGuard technology are a perfect complement to each other: the technology tells me accurately in real-time what’s ahead and the tip helps me effortlessly steer accordingly,” said John Williams, M.D., a spine surgeon from Ft. Wayne, Indiana, USA.
Company comments
“The unique and substantial benefits to patients, surgeons & OR staff directly related to the use of the PediGuard Dynamic Surgical Guidance technology have been validated by growing clinical evidence published in peer-reviewed medical journals,” says Pierre Jérôme, CEO & Co-founder of SpineGuard. “We believe that the Cannulated PediGuard will play a significant role in accelerating the shift of more spine surgeries toward minimally invasive procedures.”
About SpineGuard®
Co-founded in 2009 by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s primary objective is to establish its FDA-cleared and CE-marked PediGuard® device as the global standard of care for safer screw placement in spine surgery. SpineGuard’s mission is to make spine surgery safer. The company is also exploring other applications for its Dynamic Surgical Guidance technology platform. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.
published: June 12, 2014 in: Approval/Clearance, Spine