The SMART Trial finds favorable results for Relievant Medsystems' Intracept Procedure.
Researchers assessed the Intracept treatment in a Level 1, randomized and sham-controlled trial inclusive of 225 patients with chronic low back pain. Of the patients, 147 received the Intracept procedure and 78 underwent a sham procedure at 15 U.S. and three European Union sites.
The European Spine Journal published the trial's results.
Here are four takeaways:
1. The study revealed the protocol Intracept treatment group saw a mean Oswestry Disability Index of 20.5 points at three months. This reflects a 48 percent decline from baseline.
2. The Intracept patients also experienced statistically significant drops in pain on the Visual Analog Scale, with a 44 percent decrease in pain at six months and 41 percent drop at 12 months.
3. Researchers saw no device-related adverse events.
4. A minimally invasive procedure, the Intracept targets the basivertebral nerve via a transpedicular approach and ablates the nerve with radiofrequency energy.