Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced European Spine Journal publication of long-term data from the Level I SMART trial showing durability of improvements in pain and function beyond 5 years for patients treated with the Intracept procedure.
The recently published long-term study is a single-arm, open-label, prospective follow-up of 100 US patients (85% retention) who were successfully treated with basivertebral nerve ablation in the SMART randomized study. Mean patient follow-up was 6.4 years post-procedure (range: 5.4 – 7.8 years). The study evaluated functional impact using the Oswestry Disability Index (ODI), low back pain scores using a Visual Analog Scale (VAS), pain interventions post-BVN ablation, and patient satisfaction.
Significant differences were demonstrated at a minimum of 5 years post-procedure, including the following:
- Mean reduction in ODI of 25.95 to 16.86 from a baseline of 42.81 (p<0.001); nearly twice the minimal clinically important difference of 15
- Mean reduction in VAS of 4.38 to 2.36 from a baseline of 6.74 (p<0.001); twice the minimal clinically important difference of 2
- Nearly half of patients (47%) reported 75% or greater reduction in pain; more than a third (34%) reported complete pain resolution
- 75% of patients demonstrated both a >15-point ODI improvement and >2-point VAS improvement
- 73% reduction in active opioid use, defined as taking an opioid at least once per week
- 93% reduction in injections compared to baseline
- High patient satisfaction with the procedure
- 79% indicated they would have the procedure again for the same condition
- 65% had resumed the level of activity they enjoyed prior to low back pain
“The improvements in pain and function sustained for more than five years following the Intracept procedure are truly remarkable,” said Jeffrey Fischgrund, M.D., Chairman, Orthopedics, Beaumont Hospital, Royal Oak, MI and the principal investigator of the study. “Very few high-level studies have published such long-term results for this patient population – the magnitude and durability of improvement raises the standard for the treatment of CLBP.”
“Following publication of two Level I Randomized Control Trials, the SMART study and the INTRACEPT study, we are pleased to see such a meaningful degree of clinical improvement being maintained more than five years after patients received the Intracept procedure,” said Art Taylor, President & CEO of Relievant Medsystems. “This unparalleled level of clinical evidence demonstrating that Intracept is a highly-effective and durable therapy with a very favorable safety profile, is strongly compelling for physicians, payers, and most of all, patients suffering from vertebrogenic CLBP.”
The publication is currently available via open access and can be found at the following link: https://doi.org/10.1007/s00586-020-06448-x
About Relievant Medsystems
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 disk disease with Modic changes, a biomarker indicating that their pain is vertebrogenic in origin.
As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. Please visit www.relievant.com for a discussion of the indications, risks, contraindications, warnings, precautions and a summary of clinical trial data.
Patient Access to the Intracept Procedure
Relievant is committed to helping ensure therapy access for patients who could benefit from the Intracept procedure and employs a dedicated team of reimbursement professionals to assist in this process. Relievant works directly with payers, on behalf of patients, to obtain prior authorization for the procedure where required – providing documentation of medical necessity, educating payers regarding the substantial body of clinical evidence supporting the procedure, and working through individual payer review processes accordingly.
For additional information, please visit www.relievant.com.
i. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. European Spine Journal. 2018;27(5):1146-1156. doi:10.1007/s00586-018-5496-1
ii. Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. The Spine Journal. 2019. doi:10.1016/j.spinee.2019.05.598
iii. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. International Journal of Spine Surgery. 2019;13(2):110-119. doi:10.14444/6015