Alphatec Holdings has announced the commercial release of the SafeOp Neural InformatiX system, which has been designed to seamlessly integrate critical neural information into ATEC procedural solutions. The system has been engineered to provide surgeons with actionable information regarding both the location and the health of nerves at risk during surgery.
Specifically, the SafeOp Neural InformatiX system has been engineered with electromyography (EMG) and somatosensory evoked potentials (SSEP) to provide surgeons with actionable information regarding both the location and the health of nerves at risk during surgery. The system integrates seamlessly into operating rooms with a small footprint and wireless connectivity.
The commercial launch of the SafeOp system, according to a press release, follows successful alpha evaluations that began earlier this year; it is the last of 12 planned commercial launches for 2019, delivering on ATEC’s commitment to accelerate growth through clinical distinction.
For lateral lumbar procedures, SafeOp’s EMG nerve detection aims to give information regarding the direction and the proximity of relevant neural anatomy during the surgical approach. In addition to the access afforded with EMG, the system employs real-time SSEP nerve monitoring. Through a combination of signal amplifiers and filters, proprietary waveform classifiers, and predefined parameters, SafeOp SSEP seeks to deliver an unparalleled ability to reproducibly monitor nerve health. That capability uniquely equips surgeons with actionable information to assist in mitigating femoral nerve complications, the greatest challenge to the adoption of lateral surgery.
SafeOp is also designed to improve the safety and reproducibility of posterior fixation procedures, which encompass roughly 90% of all spine fusions. Integrated into the Invictus Posterior Fixation approach, SafeOp’s dynamic EMG technology delivers nerve detection with industry-leading speed and reliability during screw placement, reducing the risk of pedicle breach.
Pat Miles, chairman and CEO, comments: “We are launching the first reflection of the innovation that we expect to deliver through the SafeOp platform: a powerful technology that meets an unmet need for objective, intraoperative neural information during surgery. SafeOp’s unprecedented combination of nerve identification and nerve health information will be the cornerstone of ATEC clinical distinction. By providing surgeons with the information they require, when they require it, SafeOp profoundly improves the clinical experience in some of spine’s most broadly performed procedures.”
Alphatec Holdings, through its wholly-owned subsidiaries, Alphatec Spine and SafeOp Surgical , is a medical device company dedicated to revolutionising the approach to spine surgery. ATEC designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The company markets its products in the US via independent sales agents and a direct sales force.