MINNEAPOLIS, Aug. 27, 2019 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced the publication of significant and clinically-meaningful outcomes from a prospective, open-label, single-arm, multi-center study in the European Spine Journal.
This study follows previous publication of two Level I, randomized, controlled multi-center trials that showed statistically-significant and clinically meaningful outcomes versus shami and non-surgical standard careii, as well as durability of outcomes through 24 monthsiii. The Intracept procedure is indicated for patients with CLBP as a result of degenerative disk disease with Modic changes, a biomarker indicating that their pain is vertebrogenic in origin.
In the recently-published study by Truumees et al, 28 patients were enrolled consecutively at community-based spine centers, utilizing inclusion criteria reflective of “real world” spine practices – including patients having undergone prior discectomy and those utilizing extended-release narcotics. Patients were followed for three months post-procedure, with published results that were highly statistically significant and included the following:
- 30.07 point mean reduction from baseline in Oswestry Disability Index (ODI) at three months posttreatment, from 48.5 to 18.42 (p<0.0001)
- 3.50 cm mean reduction from baseline in Visual Analog Scale (VAS) at three months posttreatment, from 6.36 to 2.86 (p<0.0001)
- Significant responder rates in both ODI and VAS scores, including:
- 75% of patients reporting >20 point reduction in ODI, and
- 75% of patients reporting >2 cm decrease in VAS
- 50% of patients using opioids at baseline discontinued use by 3 months posttreatment – no patients increased dosage
- Demonstrated reductions in absenteeism and improvement in work function posttreatment
“This study utilizes representative spine care settings to further validate previously-established Level I outcomes,” said Eeric Truumees, MD, CEO and Orthopedic Surgeon, Seton Brain and Spine Institute, Austin, TX. “Patients reported significant improvements in both ODI and VAS, and were highly satisfied with their results. With straightforward, objective criteria for patient selection, Intracept is a highly effective procedure for vertebrogenic CLBP patients – who historically have had few validated treatment alternatives.”
“Building upon previously-published outcomes of the SMART and INTRACEPT Level I studies, we are pleased to see such dramatic improvements in patient status following the Intracept Procedure within a community setting,” said Kevin Hykes, CEO of Relievant Medsystems. “Relievant is committed to securing patient access to this important new treatment and we are encouraged by the positive payer reaction to the unparalleled level of clinical evidence supporting the Intracept therapy.”
The publication is currently available via open access and can be found here.
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