Relievant Medsystems’ Intracept® Procedure Achieves New Milestones

Despite the pandemic, Relievant Medsystems achieved new milestones during 2020. In May, the 5-year outcomes from their SMART trial were published in the European Spine Journal, and in October, the 12-month outcomes from their single-arm prospective study were published in the North American Spine Society Journal. These results are consistent with the company’s previous Level I outcomes and further confirm the effectiveness of the Intracept® Procedure to treat chronic vertebrogenic low back pain.

The Intracept® intraosseous nerve ablation procedure is a minimally invasive outpatient treatment that targets the basivertebral nerve (BVN) to relieve vertebrogenic chronic low back pain. The BVN is the major source of innervation within the vertebra that transmits vertebrogenic pain signals from damaged endplates. The Intracept procedure is implant-free, supported by two Level I randomized control studies, and provides durable pain relief.

Intracept Intracosseous Nerve Ablation procedureIntracept® Intraosseous Nerve Ablation procedure illustrated. Copyrighted © image provided courtesy of Relievant Medsystems, Inc. (Minneapolis, MN).

Jeffrey Fischgrund, MD, Kevin Macadaeg, MD, and Barrett Boody, MD, summarize the key findings from these studies and provide insightful commentary. Dr. Fischgrund is Chairman of the Department of Orthopaedics at Beaumont Hospital in Royal Oak, MI. Dr. Macadaeg is a Minimally Invasive Spine Specialist and Dr. Boody is an Orthopedic Spine Surgeon, both of whom practice at Indiana Spine Group in Carmel, IN.

Summary: Intraosseous Basivertebral Nerve Ablation (BVN) Study Outcomes at 5 Years and 12 Months

Dr. Fischgrund, who was instrumental in the design of Relievant’s research studies, was the principal investigator and lead author of the 5-year study.1 The SMART 5-year follow-up study included the 100 US BVN ablation arm patients who were successfully treated using the Intracept procedure in the treatment arm of the SMART Level I randomized study.2

“The continuation of improvements in oswestry disability index (ODI) and visual analogue scale (VAS) at a mean of 6.4 years post-treatment demonstrate Intracept is making a real difference, enabling almost a third of the patients to live completely free from their chronic low back pain,” Dr. Fischgrund said. “No matter how you look at it, this is a tremendous win.”

Post-procedure 5-year results include1:

  • Mean ODI reduction of 25.95 points (p<0.001) from a baseline of 42.81; nearly twice the established minimally clinically important difference (MCID) of a ≥15-point reduction
  • Mean VAS reduction of 4.38 cm (p<0.001) from a baseline of 6.74; twice the MCID of a ≥2 cm reduction
  • 47% of patients reported 75% or greater pain reduction at 5 years post-treatment
  • 34% of patients reported being pain free at 5 years post-treatment
  • 73% fewer patients reported actively using opioids (defined as taking an opioid at least once per week) compared to before Intracept
  • 93% fewer patients received injections in the 12 months prior to their 5-year study visit compared to the 12 months prior to their baseline
  • 79% of patients indicated they would have the Intracept procedure again for the same condition
  • 65% of patients resumed the activity level enjoyed prior to low back pain; in a group of patients where the majority reported having low back pain for >5 years prior to being treated with Intracept

Dr. Kevin Macadaeg was an investigator on the 5-year study and coinvestigator and lead author of the just-published 12-month prospective, open-label, single-arm study that followed 47 patients treated with the Intracept procedure for chronic vertebrogenic low back pain (CLBP).3 Unique to this study was the inclusion of patients from real world spine and pain management practice settings.

Commenting on inclusion of these patients, Dr. Barrett Boody, a coauthor of the 12-month study, pointed out the importance of studying patients that are representative of a typical spine practice. “We broadened the inclusion criteria to include the types of patients we see in our clinic every day and were able to demonstrate results that were consistent with the more restricted Level I studies. Basically, we term this as clinical effectiveness.”

Post-procedure 12-month results include3:

  • Mean ODI improvement of 32.31 points (p<0.001) from a baseline of 46.98; more than twice the MCID of a >15-point reduction
  • Mean VAS reduction of 4.31 cm (p<0.001) from a baseline of 6.82; more than twice the MCID of  a ≥2 cm reduction
  • 69% of patients reported >50% pain reduction
  • 38% of patients reported being pain free at 12 months post-treatment
  • 70% of patients using opioids at baseline were no longer actively taking opioids at 12 months post-treatment
  • In patients who had injections prior to Intracept, 96% fewer had an injection in the 12 months after the Intracept procedure
  • 84.4% of patients rated their condition as improved; 60% vastly improved
  • 89% of patients indicated they would have the Intracept procedure again

Dr. Macadaeg Explains: Combined, what do the 5-year and 12-month studies tell physicians?

The original double-blind, sham-controlled SMART trial4 demonstrated statistically significant improvements in the per protocol group in the primary outcome measure of function (reduction of ODI) at 3 months, along with clinically meaningful improvements in pain, patient satisfaction, return to work, and healthcare utilization. However, the SMART trial was a tightly controlled efficacy trial with rigorous inclusion criteria.

Clinicians, patients, and payers are most interested in how the treatment performs in real life and how long benefits from the treatment last. The prospective, single-arm study and the SMART 5-year study1 were designed to answer those questions. Our prospective, single-arm study 1-year results3 showed significant improvement in pain and function with responder rates at least twice the MCID in a typical treatment setting. The SMART 5-year study built on the existing short and mid-term evidence to show durability of the treatment benefit long-term—an average of 6.4 years after treatment.

Prior to the discovery of the vertebral endplates as a major source of CLBP, patients with vertebrogenic pain were misdiagnosed with discogenic pain. These results validate and underscore the importance of vertebrogenic pain and calls into question previously assumed pain sources in many patients with endplate changes. It might also explain why numerous disc-based treatments for CLBP (eg, heat, chemical, prosthetic) have failed to provide the level of benefits hoped. I believe the consistent and profound long-term results, combined with the minimal invasiveness and safety profile of Intracept strongly support the assessment for vertebrogenic pain and the consideration of BVN ablation for treatment of these patients in clinical practice.

Collectively, why have you integrated the Intracept Procedure into your practice?

“Both spine surgeons and minimally invasive spine specialists have embraced Intracept into our practices. In our experience, patients with chronic low back pain solely due to degenerative disc disease with Modic changes are motivated to get better and frustrated with the endless cycle of conservative care forced upon them. Likewise, the most tedious component of a spine physician’s grind is dealing with the failures of such care. Both I and my spine surgeon colleagues agree that these are the patients who could potentially benefit from Intracept,” Dr. Macadaeg added.

Disclosures
Both Dr. Fischgrund and Dr. Macadaeg have consulted to Relievant Medsystems. Dr. Boody has received a research grant.

Updated on: 11/30/20
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