Safeop Automated Neuromonitor Receives FDA Clearance To Find Nerves, Assess Their Health
SafeOp automated neuromonitoring system by Carsbad, California based company Alphatec has won FDA clearance for use in real- time intraoperative nerve location and assessment. The two complementary modalities that the system is dependent on include somatosensory evoked potential (SSEP) and electromyography (EMG). While SSEP is for the purpose of evaluating the functionality of the nerves, EMG evaluates the location and conductivity of the nerves. The system will come in use when physicians need to monitor nerve activity during surgery, especially on the spine and to identify and prevent injuries to the nerves.
Aphatecrsquo;s Chief Medical Officer, Luiz Pimenta, MD, PhD. said that neuromonitoring technology is safe and reproducible lateral surgery. He further stated that not only the SafeOp system enhanced the capability of EMG to locate nerves, but it will also facilitate monitoring the health of nerves in lumbar plexus through the entire procedure by surgeons. Ultimately, a sense of confidence to perform lateral; surgeries will be achieved by surgeons, improving the patient care scenario in totality.
The company purchased SafeOp a year ago and having received clearance it will be released in the United States market in the coming months.
Compared to other solutions available that are more susceptible to electrical noise in the operating room, the SafeOp system constitutes of an EMG algorithm that provides high- speed and validated response. While other systems in the market have up to 5 minutes of latency, SafeOp can reproducibly monitor small nerves every 3 seconds thanks to the SSEP processing that incorporated unique ldquo;signal- to- noise- ratiordquo; technology and rapid processing.
Additionally, the SafeOp is a solution uniquely equipped to address the L4/L5 spinal level which happens to be the most challenging to access but most commonly treated; in minimally invasive lateral surgical procedures.
Lastly, the SafeOp technology is designed to integrate into ATECrsquo;s broader suite of solutions for enhanced spinal outcomes and unprecedented predictability.