Sustained Relief at 12 Months
With Superiority to Standard Care through 6 Months1
- The INTRACEPT study enrolled 140 patients across 23 sites and randomization was stopped early due to statistical superiority at the pre-specified interim analysis; primary results were published in 2019, showing a highly significant difference between the Intracept arm and the standard care arm for the primary endpoint and all secondary endpoints at three months post-procedure.
- The publication reports outcomes for the full randomized trial cohort, including 6-month between arms comparisons, 12-month treatment arm results, and 6-month outcomes post-procedure for patients in the prior standard care arm that elected to receive BVN ablation upon the trial enrollment being stopped.
Mean ODI at 12 Months
Mean VAS at 12 Months
Mean ODI through 12 Months
Mean VAS through 12 Months
VAS Pain Reduction by Quadrant Improvement
Responder Rates to 12 Months
Responder rates were significant compared to baseline in the BVN ablation arm. At 12 months, 60.7% of patients reported a ≥ 20 point improvement in ODI, and 78.7% of patients reported a ≥ 2 cm reduction in VAS.
There were no serious device or procedure-related events in BVN ablation-treated patients in the study.