Long-term follow-up data from a pivotal Investigational Device Exemption study of Cerapedics’ i-FACTOR Peptide-Enhanced Bone Graft demonstrated fusion rates of 98.6% in single-level Anterior Cervical Discectomy and Fusion (ACDF) after six years in patients treated with i-FACTOR.
i-FACTOR further demonstrated spine fusion rates of 89.7%, 97.3% and 98.6% at one, two and six years, respectively, versus 85.8%, 95.8% and 97.3% for local autograft.
The six-year results were based on a single-blinded randomized controlled prospective study of i-FACTOR vs. local autograft in single-level ACDF, which included a total of 220 patient subjects with 106 in the i-FACTOR group and 114 in the local autograft control arm. Of the 22 sites from the original IDE study, 17 participated in this six-year post-approval study.
Cerapedics is currently conducting its second clinical randomized controlled trial for a transforaminal lumbar interbody fusion (TLIF) indication with 290 subjects.
Long-term follow-up data from a pivotal Investigational Device Exemption study of Cerapedics’ i-FACTOR Peptide-Enhanced Bone Graft demonstrated fusion rates of 98.6% in single-level Anterior Cervical Discectomy and Fusion (ACDF) after six years in patients treated with i-FACTOR.
i-FACTOR further demonstrated spine fusion rates of 89.7%, 97.3%...
Long-term follow-up data from a pivotal Investigational Device Exemption study of Cerapedics’ i-FACTOR Peptide-Enhanced Bone Graft demonstrated fusion rates of 98.6% in single-level Anterior Cervical Discectomy and Fusion (ACDF) after six years in patients treated with i-FACTOR.
i-FACTOR further demonstrated spine fusion rates of 89.7%, 97.3% and 98.6% at one, two and six years, respectively, versus 85.8%, 95.8% and 97.3% for local autograft.
The six-year results were based on a single-blinded randomized controlled prospective study of i-FACTOR vs. local autograft in single-level ACDF, which included a total of 220 patient subjects with 106 in the i-FACTOR group and 114 in the local autograft control arm. Of the 22 sites from the original IDE study, 17 participated in this six-year post-approval study.
Cerapedics is currently conducting its second clinical randomized controlled trial for a transforaminal lumbar interbody fusion (TLIF) indication with 290 subjects.
Copy to clipboard 
