Alphatec Holdings has received 510(k) clearance FDA for its automated SafeOp neuromonitoring system for use in real-time intraoperative nerve location and health assessment.
The Carlsbad, CA-based company 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 assesses the functional health of the spinal cord and nerves, while EMG enables surgeons to test nerves for their location, proximity, and conduction. 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.
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 Alphatec surgical approaches.
Alphatec said it 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 the company plans to expand to provide surgeons with intraoperative information beyond neuromonitoring.