Premia Spine receives FDA approval of posterior spine replacement system
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Key takeaways:
- Premia Spine received FDA premarket approval of its Total Posterior Spine facet joint replacement system.
- The system is indicated for patients with lumbar spinal stenosis and degenerative spondylolisthesis.
Premia Spine announced it has received FDA premarket approval of its Total Posterior Spine facet joint replacement system, according to a company press release.
In a randomized controlled FDA trial, researchers found patients with lumbar spinal stenosis and degenerative spondylolisthesis who received the Total Posterior Spine joint replacement system (n=115; TOPS) had better daily functional improvement as well as lower rates of new or worsening neural deficits, postoperative injections or surgical interventions, and motion or fusion failure compared with patients who underwent transforaminal lumbar interbody fusion (n=53; TLIF). The results also showed patients in the TOPS arthroplasty group had a 77% overall clinical success rate vs. 24% in the TLIF group.
“The results of this study validate our hypothesis that TOPS lumbar facet arthroplasty yields a higher rate of clinical success and fewer revision procedures compared to fusion,” Ron Sacher, CEO of Premia Spine, said in the release. “With FDA approval now secured, our priority shifts to ensuring access to the TOPS system for the countless individuals living with spinal stenosis and spondylolisthesis.”
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