Relievant Shares 4-Year Positive Data on Intracept Ablation Procedure

Relievant Medsystems announced the presentation of four-year pooled results from two clinical trials that further show its Intracept procedure’s safety, effectiveness, for vertebrogenic pain.
 
The study includes 94 patients successfully treated using the Intracept procedure and completed four-year study visits. According to the company, patients achieved “statistically significant, clinically meaningful and durable improvements in both pain and function.”
 
At four years post-Intracept, statistically significant (p<0.0001) mean improvements in Oswestry Disability Index (ODI) of 30.8 points and in numeric pain score (NPS) of 3.9 points were observed compared to baseline.
 
66.7% fewer patients were also taking opioids for low back pain as compared to baseline, and only 4.3% of patients had therapeutic injections post-procedure for the same pain etiology treated with Intracept.
 
71% of patients reported they’d resumed the level of activity they had before low back pain onset. No serious device or procedure related adverse events were reported through four years. Relievant reported positive three-year data for Intracept last month.
 
“The four-year results further support the use of the Intracept Procedure for patients with vertebrogenic back pain,” Jad G. Khalil, MD, Associate Professor of Orthopaedic Surgery and Director of the Spine Surgery Fellowship at Beaumont Hospital and lead author of the clinical trial, told the press. “Basivertebral nerve ablation is shifting the paradigm of how we understand and treat this distinct type of chronic low back pain and provides a proven treatment path for patients with this often debilitating condition.”
 
“These latest findings illustrate the long-term effectiveness of the Intracept Procedure and are consistent with previously published results that measured outcomes at five years,” added Tyler Binney, president and CEO of Relievant. “More than 10,000 patients have been treated with the Intracept Procedure and we look forward to continuing to partner with physicians to bring patients lasting relief from vertebrogenic pain.”
 
Last week, Relievant released next-generation instruments for the Intracept procedure.