Relievant Medsystems, a privately held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), announced 24-month results from a Level 1, prospective, randomized, multi-center trial (INTRACEPT) that further validate the safety, effectiveness, and durability of the Intracept® Procedure for patients with vertebrogenic CLBP.
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The study reported outcomes for patients in the Intracept Procedure treatment arm that completed a 24-month follow-up visit. These patients achieved statistically significant and clinically meaningful improvements in pain, function, and quality of life from baseline at all follow-up timepoints through 24 months.
Patients in the Intracept Procedure treatment arm realized a 28.5 point (p<0.001) mean reduction in Oswestry Disability Index (ODI) and a 4.1 cm mean reduction in Visual Analog Scale (VAS) from baseline to 24 months post-procedure.
“This long-term data, from the treatment arm of our second Level I RCT, again show that patient benefits in function and pain persist following the Intracept Procedure,” said Tyler Binney, President and Chief Executive Officer, Relievant Medsystems.
“Not only are these 24-month results similar to the positive outcomes previously reported, including the 5-year results from our Level 1 SMART Trial, they also are consistent with the life-changing results physicians are seeing with their own vertebrogenic pain patients, validating the important role of the Intracept Procedure in the CLBP care pathway.”
The INTRACEPT study randomized 140 patients across 20 sites, and enrollment was stopped early due to statistical superiority at the pre-specified interim analysis. Primary results were published in 2019, showing a significant difference between the Intracept arm and the standard care arm for the primary endpoint and all secondary endpoints at three months post-procedure.
Relievant Medsystems is a privately held medical device company that is transforming the treatment of Chronic Low Back Pain (CLBP) with the Intracept Procedure – a novel, clinically proven and commercially available treatment designed to improve the quality of life for the millions of patients suffering from CLBP from degenerative disc disease with Modic changes, a biomarker indicating that their pain is vertebrogenic in origin.