Issue link: https://beckershealthcare.uberflip.com/i/1365724
UNPARALLEDED EVIDENCE Long-Term Relief Following the Intracept ® Procedure: 5 Year Outcomes 1 50 40 30 20 10 0 5 YEARS n=100** 24 Mo. n=106* 12 Mo. n=128* 6 Mo. n=128* 3 Mo. n=128* BASELINE n=128* *n=Global PP **n=US PP 22.1 21.6 22.6 18.8 16.9 42.4 ODI POINTS Mean ODI Over Time ODI decrease of 61% in patients with a 5 year follow-up Mean ODI Over Time 10 8 6 4 2 0 5 YEARS n=100** 24 Mo. n=106* 12 Mo. n=128* 6 Mo. n=128* 3 Mo. n=128* BASELINE n=128* *n=Global PP **n=US PP 3.8 3.74 3.96 3.13 2.35 6.73 VAS SCORE Mean VAS Over Time VAS decrease of 65% in patients with a 5 year follow-up Mean VAS Over Time Indications and Risks The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. Please see the device labeling for a discussion of the risks, contraindications, warnings and precautions. 1. Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5 year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. epub May 25, 2020. https://doi.org/10.1007/s00586-020-06448-x 50% 40% 30% 20% 10% 0% < 25% Reduction 25-49% Reduction 50-74% Reduction 75-100% Reduction 100% Reduction 12% 22% 19% 47% 34% Proportion of Patients by % VAS Reduction (Baseline to 5 Years) Proportion of Patients by % VAS Reduction (Baseline to 5 Years) MKT 0249