Alphatec, out of Carsbad, California, won FDA clearance for the SafeOp automated neuromonitoring system for use in real-time intraoperative nerve location and assessment. The system relies on somatosensory evoked potential (SSEP) and and electromyography (EMG) as the two complementary modalities, one for evaluating the functionality of nerves and the other their location and conductivity. Physicians can use the technology to identify and prevent injuries to the nerves and to monitor nerve activity during surgery, particularly on the spine.
“Neuromonitoring technology is critical for a safe and reproducible lateral surgery,” said Luiz Pimenta, MD, PhD, Alphatec’s Chief Medical Officer. “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 SafeOp system is slated to be released in the United States in the coming months.
Of note, Alphatec purchased SafeOp, the company, about a year ago.
Some features of the SafeOp system, according to Alphatec:
- An EMG algorithm that provides high-speed, validated response feedback unlike other solutions on the market that are more susceptible to electrical noise in the operating room
- A SSEP processing that incorporates unique “signal-to-noise ratio” technology and rapid processing, allowing SafeOp to reproducibly monitor small nerves every 3 seconds, while other systems on the market have up to 5 minutes of latency
- A solution that is uniquely equipped to address the L4/L5 spinal level in minimally invasive lateral surgical procedures, the level most difficult to safely access but most commonly treated
- Technology that is designed to integrate into ATEC’s broader suite of solutions for unprecedented predictability and improved spine outcomes
Product page: SafeOp neuromonitoring solution…