Cerapedics has announced long-term follow-up data from its pivotal investigational device exemption (IDE) study of the i-FACTOR peptide-enhanced bone graft. Published data demonstrate fusion rates in single-level anterior cervical discectomy and fusion (ACDF) of 98.6% after six years in patients treated with i-FACTOR and, according to a press release, reinforce the company’s commitment to capturing long-term clinical evidence.
These results further support the safety and efficacy profile of i-FACTOR at one and two years, as published in the journals Spine and Neurosurgery, Cerapedics claims.
I-FACTOR has proven statistical superiority versus local autograft in overall success at one- and two-year endpoints for single-level ACDF, as well as demonstrating 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.
Some 220 of the original 319 patients in the company’s IDE study were observed over six years or 72 months. The six-year results, published earlier in 2023 in Neurosurgery, were based on a single-blinded, randomised controlled prospective study of i-FACTOR compared to 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.
“Clinicians are looking for long-term safety and efficacy data to support decision-making about the safest and most effective spine technologies,” said Paul Arnold (The Carle Illinois College of Medicine, Urbana, USA), principal investigator and author of the study’s 12-, 24- and 72-month publications. “In this unique, long-term follow-up data from a pivotal IDE study, i-FACTOR met all four FDA [Food and Drug Administration]-mandated non-inferiority success criteria, and demonstrated safety and efficacy in single-level anterior cervical discectomy and fusion compared to autograft at 12, 24, and 72 months.”
“These results clearly demonstrate the efficacy rates and safety profile of i-FACTOR over an extended period, and also reflect Cerapedics’ commitment to producing the highest-quality evidence on the use of our products,” said Valeska Schroeder, CEO of Cerapedics. “Combined with the IDE study results, these data add to the clinical understanding of i-FACTOR’s efficacy and safety. Although there are numerous other bone graft options, many have not undergone the same level of testing. These data are impactful for insurance payers who seek Level 1 evidence as they make coverage decisions.”
According to the recent release, i-FACTOR is available in the USA through a premarket approval, and Cerapedics is currently conducting its second clinical randomised controlled trial for a transforaminal lumbar interbody fusion (TLIF) indication with 290 subjects.