Relievant announces publication of SMART trial 24-month results

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Relievant Medsystems have announced the publication of 24-month results from the SMART trial in the International Journal of Spine Surgery. A total of 106 of the 128 treatment arm patients in the SMART trial completed 24-month follow up. Data at three months and 12 months from the Level I SMART trial, a randomised, multicentre trial comparing the Intracept procedure to sham, was previously published.

The 24-month data demonstrated sustained improvement in pain, function, and resource utilisation. Key results from the publication include:

  • 54% reduction in Oswestry Disability Index (ODI) from baseline to 24 months
  • 53% reduction in Visual Analog Scale (VAS) from baseline to 24 months
  • Elimination of opioids in 46.4% of patients who were taking opioids at baseline
  • Reduction in number of patients receiving spinal injections from 57.5% in the year leading up to enrollment to 7.5% in the two years following treatment
  • No device related serious adverse events were reported

“It is really exciting to see the improvement in pain and function previously reported at 3 and 12 months continued through 24 months,” said Alfred Rhyne, orthopaedic spine surgeon, OrthoCarolina, Charlotte, USA. “While Intracept is not intended to treat all patients suffering from CLBP, the SMART trial has proven that Type 1 or 2 Modic endplate changes on MRI represent an objective, validated biomarker for the subset of CLBP patients that suffer from vertebrogenic pain, and who have shown in this trial to gain significant and durable pain relief with the Intracept Procedure.”

“The SMART trial provides evidence that the Intracept Procedure not only improved pain and function, it also reduced opioid and spinal injection usage,” said Kevin Hykes, CEO of Relievant Medsystems. “Given the current opioid epidemic and the rising cost of healthcare, we are thrilled to offer a meaningful solution that provides lasting pain relief to millions of people suffering from chronic vertebrogenic low back pain.”


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