SpineGuard Adds to PediGuard Line of Surgical Instruments

SpineGuard has expanded the lineup of products in its dynamic surgical guidance platform for enhanced pedicle screw placement. The company recently released its Bevel-Tip Cannulated PediGuard during the World Congress of Minimally Invasive Spine Surgery and Techniques in Paris, France (June 11-14).

Minimally invasive surgery (MIS) for spine results in less disruption of the muscles, can result in decreased operative blood loss and reduced soft tissue destruction, which all allows for quicker recovery and faster return to normal function. MIS, however, can make pedicle screw placement challenge because surgeons must compensate for the lack of visual landmarks and tactile feel with massive use of fluoroscopy, exposing themselves and the rest of the operating room (O.R.) team to considerable amounts of radiation.

In addition to unacceptably high rates of misplacements that can lead to a number of serious complications for patients—such as spinal cord damage resulting in various degrees of neurological impairment—pedicle screws placed with conventional techniques show high exposure of surgeons, staff and patients to radiation. Indeed, spine surgeons more than double their lifetime radiation exposure limits in less than 10 years when using fluoroscopy and/or X-ray to guide pedicle screw placement.

Cannulated PediGuard expands the applicability of pedicle screw placement with real-time feedback, according to the company. Nearly one million spine procedures using pedicle screws are performed annually worldwide, according to iData Research. About 15 percent of such procedures are now done via a minimally invasive approach; this percentage is rapidly growing driven by innovation and surgeon training, according to iData.

“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’ (drifting) 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, Ind.

“The unique and substantial benefits to patients, surgeons and O.R. 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,” said Pierre Jérôme, CEO and 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.”

Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and biomedical engineer Alain Vanquaethem, PediGuard is a handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. More than 30,000 procedures have been performed with PediGuard worldwide, according to the company.

According to data cited by the company, several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98 percent of pedicle breaches, presents an average screw placement accuracy of 97 percent (vs. 92 percent on average for navigation), provides threefold less pedicle perforations than with free-hand technique and a threefold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25-30 percent and decreases by 15 percent the time for pedicle screw placement.

SpineGuard has offices in San Francisco, Calif., and Paris, France.