Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced the North American Spine Society Journal publicationi of results from an effectiveness study showing that the significant improvements in function and pain initially reported at an interim analysis of three monthsii following the Intracept Procedure remained significant through one year.
The prospective, open-label, single-arm study followed 47 patients treated with the Intracept procedure for chronic low back pain through 12 months at two community-based practices – led by Kevin Macadaeg, MD at Indiana Spine Group and Eeric Truumees, MD at Ascension Texas Spine and Scoliosis Center. Inclusion criteria were more permissive than those employed in the previously-reported SMART and INTRACEPT randomized controlled trials (RCT’s), including patients having undergone prior discectomy and utilizing extended-release narcotics, reflective of patients found in “real world” spine and pain practices versus previous highly controlled study protocols. Results 12-months
Results 12-months post-procedure included the following:
- Mean ODI improvement of 32.31 (p<0.001) from a baseline of 46.98 (more than twice the established minimal clinically important difference (MCID) of 15)
- Mean VAS reduction of 4.31 (p<0.001) from a baseline of 6.82 (more than twice the established MCID of 2)
- 69% of patients reported >50% reduction in pain while 38% reported being pain free
- 70% of the patients who were using opioids at baseline were no longer actively using opioids at 12 months (> 1 time per week)
- 96% of the patients who had injections prior to treatment did not have any injections in the 12 months after treatment
- 84.4% of patients rated their condition as improved (60% vastly improved) and 89% indicated they would have the procedure again
“Previous, highly-controlled studies have shown the positive outcomes achieved following the Intracept procedure are both significant and durable,” said Kevin Macadaeg, MD, Minimally Invasive Spine Specialist at Indiana Spine Group and the principal investigator of the study, “This study demonstrates that patients treated in a typical spine practice can achieve similar outcomes a year post-procedure as those previously reported – meaningful improvements in function and pain that reduce healthcare utilization and improve patient satisfaction.”
“It’s important for physicians to know that patients in their own practice can achieve similar improvements as those reported in the significant body of evidence supporting the Intracept procedure – including two Level I RCTs and a long-term, 5-year study,” said Art Taylor, President & CEO of Relievant Medsystems. “This evidence further indicates that the effectiveness and strong safety profile of the Intracept procedure can be achieved at typical spine practices, bringing relief to vertebrogenic CLBP patients who have often suffered from their condition for years. Physicians, payers, and most of all, CLBP patients are excited by the unparalleled level of evidence supporting the Intracept procedure in this difficult-to-treat population.”
The publication is currently available via open access and can be found at the following link: https://doi.org/10.1016/j.xnsj.2020.100030
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, minimally invasive 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. K. Macadaeg , E. Truumees , B. Boody , E. Pena , J. Arbuckle II , J. Gentile , R. Funk , D. Singh , S. Vinayek , A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results, North American Spine Society Journal (NASSJ) (2020). https://doi.org/10.1016/j.xnsj.2020.100030
ii. Truumees, E., Macadaeg, K., Pena, E. et al. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Eur Spine J 28, 1594–1602 (2019). https://doi.org/10.1007/s00586-019-05995-2