Alphatec Announces FDA Clearance of its Automated SafeOp Neuromonitoring System to Address Significant Unmet Needs in Spine Surgery

- February 25th, 2019

Alphatec Holdings (NASDAQ:ATEC) has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its automated SafeOp neuromonitoring system. As quoted in the press release: I could not be more excited to integrate this revolutionary technology into our growing number of spine approaches,” said Pat Miles, Chairman and Chief Executive Officer. … Continued

Alphatec Holdings (NASDAQ:ATEC) has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its automated SafeOp neuromonitoring system.

As quoted in the press release:

I could not be more excited to integrate this revolutionary technology into our growing number of spine approaches,” said Pat Miles, Chairman and Chief Executive Officer. “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.”

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.

“Surgeons yearn for information to enable better surgery,” added Miles. “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.”

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 ATEC surgical approaches.

“Neuromonitoring technology is critical for a safe and reproducible lateral surgery,” said Luiz Pimenta, MD, PhD, ATEC’s Chief Medical Officer and pioneer of the lateral surgery approach.  “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.”

Click here to read the full press release.

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