Relievant announces publication of SMART trial 24-month results
Intracept® Procedure Demonstrates Durable Results at 24 Months.
MINNEAPOLIS – April 24, 2019 – Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), today 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 3 months and 12 months from the Level I SMART trial, a randomized, multi-center trial comparing the Intracept Procedure to sham, was previously published.
The 24-month data demonstrated sustained improvement in pain, function, and resource utilization. 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 2 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, MD, Orthopedic Spine Surgeon, OrthoCarolina, Charlotte, NC. “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.”
About Relievant Medsystems
Relievant Medsystems is a privately-held medical device company that has developed a novel, clinically proven treatment option to improve the quality of life for millions of patients suffering from chronic vertebrogenic low back pain.
About Chronic Low Back Pain (CLBP)
Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the US, of whom over 70 percent fail to find adequate relief with conservative care and are not candidates for surgery. Until recently, the intervertebral discs have been thought to be the primary source of pain, also referred to as discogenic pain, in many patients with CLBP. Relievant’s Intracept Procedure is supported by ground-breaking anatomic and clinical research that has demonstrated that the vertebral body endplates are a significant source of pain in many of these patients. This pain is now referred to as vertebrogenic pain. It is estimated that over five million CLBP patients in the US have vertebrogenic pain and are candidates for the Intracept Procedure.
About the SMART Clinical Trial
The SMART Clinical Trial was a Level I, prospective, randomized, double-blind, sham-controlled clinical trial evaluating the reduction of pain in patients with chronic vertebrogenic low back pain. The primary endpoint was the evaluation of patient improvement in Oswestry Disability
Index (ODI) at three months compared to baseline between treatment and sham populations. The SMART Trial enrolled 225 patients at 15 sites in the United States and 3 sites in Germany. Patients that were randomized to the treatment arm were followed through 24 months.
About the Intracept Procedure
FDA has cleared Relievant’s Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
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 risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.