Relievant Medsystems Releases Positive Data for Nerve Ablation Procedure

Relievant Medsystems, a company developing solutions to diagnose and treat vertebrogenic low back pain, announced publication of three-year pooled results from two prospective clinical trials that further validate safety, effectiveness, and long-term durability of the Intracept procedure for vertebrogenic pain.
 
Published in Interventional Pain Medicine, the study includes 95 patients at 22 study sites who were successfully treated using Intracept and finished three-year study visits. Patients achieved “statistically significant, clinically meaningful and durable improvements in both pain and function.”
 
Statistically significant (p<0.0001) 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 also found 74% fewer patients were actively using opioid medications for low back pain and 84% fewer patients needed spinal injections for the same pain source and treatment level.
 
26.3% of patients reported being 100% pain-free, and 71% said they’d returned to the activity level they enjoyed before having chronic low back pain. 86% said they’d have the procedure again for the same condition, and no serious adverse events were reported.
 
“These aggregated three-year results demonstrate the sustained effectiveness of basivertebral nerve ablation in improving patients’ pain, productivity and quality of life while decreasing their healthcare utilization,” Matthew Smuck, MD, Chief of Physical Medicine & Rehabilitation and Professor of Orthopaedic Surgery at Stanford University and lead author of the study, told the press. “The data also demonstrate that vertebrogenic pain is a distinct source of anterior column low back pain that is identified using an objective imaging biomarker. 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.”
 
The Intracept procedure is a same-day, outpatient procedure that uses targeted radiofrequency (RF) energy to stop the basivertebral nerve (BVN) from sending pain signals to the brain. It takes about an hour to perform.
 
“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.”