Alphatec receives FDA clearance for SafeOp spine surgery neuromonitoring system: 5 points

Spinal Tech

Alphatec received FDA 510(k) clearance for its automated SafeOp neuromonitoring system.

Five things to know:

1. The SafeOp system will initially focus on minimally invasive lateral spine procedures, but it expected to be leveraged into multiple Alphatec surgical approaches.

2. The system uses two intraoperative neurophysiological modalities: somatosensory evoked potential to assess the health of the spinal cord and nerves, and electromyography to test nerves for their location, proximity and conduction.

3. The SafeOp automated somatosensory evoked potential technology has successfully been used in more than 1,000 surgeries to identify potential nerve injury from patient positioning.

4. The FDA clearance expands the system to include more advanced electromyography algorithms.

5. Alphatec expects to fully launch the SafeOp system in spring. It is the first solution delivered as part of the Alpha Informatix platform.

"Neuromonitoring technology is critical for a safe and reproducible lateral surgery," said Alphatec CMO and lateral surgery approach pioneer Luiz Pimenta, MD, PhD. "The SafeOp system has not only improved the [electromyography] capability to find nerves, but now surgeons will be able to monitor the health of nerves in the lumbar plexus throughout the entire procedure." 

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