Companion Spine earned the FDA’s premarket approval for its DIAM spinal stabilization system, according to a Dec. 15 news release.
DIAM is the first posterior motion-preserving device approved in the U.S., and it is designed to address moderate-to-severe primary low back pain secondary to degenerative disc disease. The system earned the FDA’s breakthrough device designation in 2021.
Clinical trials have found DIAM was a stronger option to nonoperative care and had a 1.6% rate of of device-related serious adverse events and no device migrations or device failures in long-term follow-ups.
Over the last 20 years, DIAM has been used in more than 200,000 patients globally.
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