Intracept, a minimally invasive, FDA-cleared, same-day, outpatient procedure, treats chronic vertebrogenic low back pain. It uses targeted radiofrequency energy to ablate the basivertebral nerve (BVN), stopping it from transmitting pain signals to the brain. The procedure takes approximately one hour to perform.
Minneapolis-based Relievant’s three-year pooled results validated the safety, effectiveness and long-term durability of Intracept. The company published the study results in Interventional Pain Medicine. Those results proved consistent with previously published long-term results measuring Intracept outcomes at five years.
The results included 95 patients successfully treated with Intracept across 22 study sites. Patients achieved statistically significant, clinically meaningful and durable improvements in both pain and function.
Results from the Relievant study
At three-years post-procedure, the study observed statistically significant improvements of 31.2 points and 4.3 points were observed compared to baseline, for mean Oswestry Disability Index (ODI) and mean numeric pain score (NPS), respectively. The study demonstrated that 74% fewer patients actively used opioid medications for low back pain. Additionally, 84% fewer patients required spinal injections for the same pain source and treatment level.
Other key findings included 26.3% of patients reported themselves as 100% pain-free. Nearly three-quarters of patients indicated a return to the level of activity they enjoyed prior to their back pain. Additionally, 86% indicated their preference toward having the procedure again for the same condition. Relievant also reported no serious device- or procedure-related adverse events.
“We are encouraged to see positive outcomes consistent with results from multiple clinical trials, including two Level I randomized controlled trials, that demonstrate the long-term durability of the Intracept Procedure,” said Tyler Binney, president and CEO of Relievant Medsystems. “These outcomes represent improved quality of life for patients and we are committed to continuing to provide vertebrogenic pain relief to the millions of individuals with this often debilitating condition.”
Dr. Matthew Smuck, lead author of the study, added that the data also demonstrated the effectiveness of correct diagnoses.
“The exciting thing about this is that many patients with this diagnosis were previously misdiagnosed with discogenic back pain, a condition with no reliable treatments currently, and they can now be effectively treated when correctly diagnosed with vertebrogenic pain,” Smuck said.
