Spine surgeons back device that alerts for breaches

PARIS & SAN FRANCISCO – SpineGuard (FR0011464452 – ALSGD) announced that its PediGuard platform has been adopted by leading spine surgeons in the department of orthopaedic surgery at Kobe University Graduate School of Medicine (KOL). This early adoption of PediGuard at one of the oldest and largest national universities in Japan, which is also consistently one of the highest-ranking national universities in the country, comes on the heels of SpineGuard recently receiving product certification ("Ninsho") to market its Classic and Curved PediGuard? products in Japan.

Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer, 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 28,000 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.

The Curved PediGuard takes the place of the standard gearshift and facilitates pilot hole preparation for accurate screw placement. PediGuard’s bipolar tip can alert the surgeon prior to a breach by accurately analyzing the electrical conductivity of the surrounding tissues. The surgeon is informed in real time by changes in pitch and cadence of audio feedback and a flashing LED light. (SpineGuard)

“PediGuard worked well in my operation,” said Dr Kotaro Nishida, M.D., Ph.D., associate professor, Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine. “It will give Japanese spine surgeons a sense of security in making a reliable pedicle screw pathway.”

“PediGuard was even more helpful than I had expected before the operation,” said Dr Koichiro Maeno, M.D., Ph.D., assistant professor, Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine. “I am eager to use PediGuard on patients with different bone properties and in cases where the point of insertion varies.”

Pedicle screw-based stabilization has become the gold standard for treating spine instabilities and deformities. This market is growing due to the 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.

Japan is the second-largest market in spine afteNike LunarEpic Low Flyknit