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February 26, 2019

FDA clears Alphatec neuromonitoring system for spine surgery

The US Food and Drug Administration (FDA) has granted 510(k) clearance to medical device company Alphatec’s SafeOp neuromonitoring system for use in spine surgery procedures.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to medical device company Alphatec’s 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 (IONM) features.

Somatosensory evoked potential (SSEP) 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.”

According to Alphatec, the SafeOp automated SSEP technology has been leveraged for more than 1,000 surgeries to detect potential nerve injury from patient positioning, as well as to monitor peripheral nerves in spine surgery.

The latest FDA clearance expands the system to include more advanced algorithms for EMG.

Alphatec chairman and CEO Pat Miles said: “Surgeons yearn for information to enable better surgery. 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.”

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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 said: “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.”

Furthermore, the company intends to extend the use of the Alpha Informatix to provide intraoperative information beyond neuromonitoring.

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