SpineGuard (EPA:ALSGD) said today it won CE Mark approval in the European Union for its DSG threaded drill system designed to eliminate the need for probe drilling during pedicle screw placement.
The DSG system includes a DSG cannulated threaded drill, DSG pin with proprietary DSG bipolar sensor embedded and a DSG handle assembly which reads and translates signals from the sensor, the company said.
“This novel application of our DSG technology is the fruit of a close collaboration between our R&D team and our expert consulting surgeons. In line with healthcare systems expectations, SpineGuard continues to bring to market disruptive products designed to enhance the safety and efficiency of surgical procedures,” CTO Stéphane Bette said in prepared remarks.
The company said the DSG threaded drill had been used in its 1st surgery, a thoraco lumbar scoliosis correction, in Lille, France’s Centre Hostpiatlier Universitaire by Dr. Richard Assaker.
“As a long-standing user of PediGuard probes, I find that this smart threaded drill is a useful technical improvement. It allows to prepare the entry point, redirect the trajectory when needed and remain in cancellous bone. If appropriate, we can also cross the cortical wall with a very high level of precision, ” Assaker said in a press release.
In June, Spineguard said it received Chinese clearance to sell its Pediguard, a handheld surgical device designed to help guide proper spine screw placement.
The spine market in China is the 2nd-largest behind the U.S., the Vincennes, France-based company said, and is projected to be worth more than $1 billion by 2019.
