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Alphatec secures FDA 510(k) clearance for automated neuromonitoring system


The US Food & Drug Administration (FDA) has granted 510(k) clearance for Alphatec's automated SafeOp neuromonitoring system to be used in real-time intraoperative nerve location and health assessment.


Image: Alphatec wins FDA approval for SafeOp. Photo: Courtesy of ddpavumba/FreeDigitalPhotos.net.

Alphatec said the next-generation technology of the SafeOp system represents a significant advancement in two intraoperative neurophysiological monitoring (IONM) modalities: somatosensory evoked potential (SSEP), and electromyography (EMG).

SSEP is useful in assessing the functional health of the spinal cord and nerves, while EMG offers surgeons to test nerves for their location, proximity and conduction.

The SafeOp automated SSEP technology has been used in more than 1000 surgeries to identify potential nerve injury from patient positioning and has shown its reliability in monitoring peripheral nerves in spine surgery. With the clearance from FDA, the system can now include more advanced algorithms for EMG.

Alphatec chairman and CEO Pat Miles said: “I could not be more excited to integrate this revolutionary technology into our growing number of spine approaches. Many of us at ATEC were previously instrumental in developing, validating, and marketing a neuromonitoring platform that became foundational to a billion-dollar spine company. The SafeOp solution is better.  It has no peer and it elevates the requirements for others to participate.

“Today, we have raised the bar in delivering objective actionable information that drives safer and more reproducible spine surgery.”

The SafeOp system will initially focus on resolving the significantly unmet clinical needs in minimally invasive lateral procedures, and it can also be used into multiple ATEC surgical approaches.

The company stated that the foundational technology for SafeOp was obtained as part of SafeOp Surgical’s acquisition in last March and the system has been further developed over the past year.

SafeOp Neuromonitoring system combines real-time, automated EMG and SSEP for objective assessment of nerve location and nerve health throughout the entire surgical procedure.

The EMG algorithm is claimed to be offering high speed, validated response feedback.

SSEP processing includes a ‘signal-to-noise ratio’ technology and rapid processing, that allows SafeOp to reproducibly monitor small nerves every 3 seconds, while other systems on the market have up to 5 minutes of latency.

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. The development of this system demonstrates ATEC’s commitment to revolutionize how the world approaches spine surgery.”