Relievant Medsystems today released the results from the Smart trial of its Intracept intraosseous nerve ablation system exploring its usefulness at treating chronic lower back pain, touting significant decreases in pain from baseline at three months.
The Intracept system is designed to use radio frequency energy delivered through specially designed instruments during a minimally invasive surgical procedure to access and ablate the basivertebral nerve to prevent it from transmitting pain signals.
Results from the trial were reported in the European Spine Journal, the Sunnyvale, Calif.-based company said.
“The Intracept procedure represents a novel, minimally invasive option for the over 5 million indicated patients in the U.S who are suffering from CLPB for whom today’s treatment options have proven ineffective. Our ability to treat these patients early in the CLBP disease continuum can potentially avoid the later need for opioids, or more costly and invasive therapies,” prez & CEO Kevin Hykes said in a press release.
The Smart trial is a randomized, sham-controlled, double-blind clinical trial of 225 patients that took place across 15 US sites and three EU sites exploring the use of the system for treating chronic lower back pain, Relievant Medsystems said.
Results indicated a statistically significant difference between patients treated with Intracept and those in the sham treatment cohort, with a 48% decrease from baseline scores on the Oswestry Disability Index at 3 months.
Patients also showed statistically significant decreases in pain at six and twelve months as measured by the Visual Analog Scale, sustaining a 44% and 41% decrease in pain at each period, respectively. No adverse device-related events were reported.
“The Smart trial confirms that Intracept is an important, new solution for CLBP with the strong results demonstrated by the significant and durable ODI decreases in this highly rigorous sham controlled randomized trial. The significant improvement in pain and function demonstrated by the Smart trial provides clear proof of the efficacy of this treatment. We are honored to have these data published in the European Spine Journal and look forward to building upon these results,” principal study investigator Dr. Jeffrey Fischgrund of Beaumont Hospital said in a prepared statement.
