The U.S. FDA has granted 510(k) clearance to Carlsbad, Calif.-based Alphatec for its SafeOp neuromonitoring system for use in spine surgery procedures. Based on the Alpha Informatix platform, the automated system is designed for intraoperative nerve location and health assessment in real time.
It comprises two intraoperative neurophysiological monitoring features. Somatosensory evoked potential enables the functional health evaluation of the spinal cord and nerves, while electromyography (EMG) facilitates testing of nerves for their location, proximity, and conduction.
The latest FDA clearance expands the system to include more advanced algorithms for EMG. “Surgeons yearn for information to enable better surgery,” says Alphatec chairman and CEO Pat Miles. “SafeOp not only provides actionable intraoperative information regarding nerve location during access but for the first time, it also allows surgeons to monitor patient nerve health, in real-time, during surgery.”
Initially, the SafeOp system will be used in minimally invasive lateral procedures, with plans to expand its application into various ATEC surgical approaches. The device will be commercially available over the coming months.
Alphatec chief medical officer Luiz Pimenta adds: “The SafeOp system has not only improved the EMG capability to find nerves but now surgeons will be able to monitor the health of nerves in the lumbar plexus throughout the entire procedure. This technology will provide more surgeons with the confidence to perform lateral surgeries and will improve patient care.”
The company also intends to extend the use of the Alpha Informatix to provide intraoperative information beyond neuromonitoring.
