Alphatec announces FDA clearance of automated SafeOp neuromonitoring system


It was announced recently that Alphatec has received 510(k) clearance from the US Food & Drug Administration (FDA) for its automated SafeOp neuromonitoring system for use in real-time intraoperative nerve location and health assessment.

According to a press release, the technology of the SafeOp system represents a “significant advancement” in two intraoperative neurophysiological monitoring (IONM) modalities: somatosensory evoked potential (SSEP), and electromyography (EMG). SSEP assesses the functional health of the spinal cord and nerves, while EMG enables surgeons to test nerves for their location, proximity, and conduction.

Alphatec remarks that the SafeOp automated SSEP technology has been successfully used in more than 1,000 surgeries to identify potential nerve injury from patient positioning, and has demonstrated reliability in monitoring peripheral nerves in spine surgery. The current 510k clearance expands the system to include more advanced algorithms for EMG.

Pat Miles, chairman and chief executive officer of Alphatec, commented: “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.”

The SafeOp system’s initial focus will be on resolving the “significant unmet clinical need” in minimally invasive lateral procedures, but it can and will be leveraged into multiple ATEC surgical approaches.

“Neuromonitoring technology is critical for a safe and reproducible lateral surgery,” said Luiz Pimenta, Alphatec’s chief medical officer and pioneer of the lateral surgery approach. “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 expects full commercial launch of the SafeOp system in Spring 2019. It is the first solution delivered as part of the Alpha Informatix platform, which Alphatec plans to expand to provide surgeons with intraoperative information beyond neuromonitoring.


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