Alphatec (NSDQ:ATEC) said today that it won FDA 510(k) clearance for its SafeOp neuromonitoring system, now cleared for use in real-time intraoperative nerve location and health assessment.
The clearance expands the indications for the next-gen system to include more advanced algorithms for electromyography, which is used to test nerves for location, proximity and conduction. The system also features somatosensory evoked potential monitoring, which assesses the functional health of the spinal cord and nerves, the Carlsbad, Calif.-based company 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. 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,” chair & CEO Pat Miles said in a prepared statement.
The company said that the initial focus of the device will be on resolving unmet clinical need in minimally invasive lateral procedures, but added that it expects to leverage the technology into multiple surgical approaches.
“Neuromonitoring technology is critical for a safe and reproducible lateral surgery. 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,” chief medical officer Dr. Luiz Pimenta said in a press release.
Alphatec said it expects to initiate a full commercial launch of the system this spring.
Earlier this month, Alphatec said that a U.S. District Court granted a stay in a the patent litigation between it and competitor NuVasive (NSDQ:NUVA) while the U.S. Patent and Trademark Office considers recently filed challenges from Alphatec.
