SpineGuard Gets Expanded OK for its Devices in Mexico
And the news just keeps on coming from medical device company SpineGuard. The company recently received additional regulatory clearance from COFEPRIS, Mexico’s healthcare regulatory authority, to sell the Curved and Curved XS PediGuard devices in Mexico. SpineGuard previously received clearance for its Classic and Cannulated PediGuard devices.
“This additional regulatory approval completes our offering into the substantial market of Mexico. Mexico’s spine surgeons will now benefit from all of the PediGuard features, including directionality and miniaturization, thus minimizing complications due to cortical breaches and reducing their exposure to radiation as a result of less dependence on fluoroscopy,” said Pierre Jérôme, CEO and co-founder of SpineGuard.
Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and biomedical engineer Alain Vanquaethem, PediGuard—used in screw placement for spinal surgery—is a handheld device capable of alerting surgeons to potential pedicular or vertebral breaches (when screws are pushed too far and touch the nerve). Real-time feedback is provided via audio and visual signals.
Over 28,000 procedures have been performed with PediGuard worldwide, the company claims.
SpineGuard was formed in 2009, by Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision.
The company has offices in San Francisco, Calif., and Paris, France.