Cerapedics today released the results from the pivotal FDA investigational device exemption trial of its i-Factor peptide enhanced bone graft for use in anterior cervical discectomy and fusion procedures. Data from the study was published electronically in the journal Spine.
The Westminster, Colo.-based company said the trial demonstrated appropriate safety and efficacy and met all 4 of the FDA’s mandated non-inferiority success criteria when compared to a local autograft in single-level ACDF procedures for cervical radiculopathy.
“The results of this landmark IDE study further reinforce our belief that i-Factor bone graft represents an important advance in ACDF procedures and may offer an alternative to autograft harvesting or other growth Factor technologies. We are pleased to have these data published by such a prominent and well-respected journal in the field of spine surgery,” prez Jeffrey Marx said in a prepared statement.
The prospective, randomized, single-blinded study reported an 88.9% fusion rate in patients treated with the iFactor, versus 85.8% in patients who received autografts.
Patients in both the iFactor and autograft groups reported similar improvements in NDI, at 28.6 and 27.4 respectively, as well as neurological success rates of 93.7% and 93% respectively. There was no difference reported in the rate of adverse events.
In a responder analysis for overall success in all 4 primary outcomes returned a 69% success rate for the iFactor compared against a 57% rate for patients treated with an autograft.
“Until now alternatives to autograft bone for use in ACDF procedures had not been evaluated in rigorous randomized, controlled studies. This study demonstrates that treatment with i-Factor bone graft resulted in similar and on some metrics superior outcomes compared to local autograft bone,” study co-investigator Dr. Paul Arnold of the University of Kansas Medical Center said in a press release.
In November, Cerapedics said it won FDA premarket approval for its I-Factor peptide enhanced bone graft for use in anterior cervical discectomy and fusion procedures for patients with degenerative cervical disc disease.
Westminster, Colo.-based Cerapedics said the I-Factor graft is the 1st bone graft approved for use in cervical spine procedures and the 2nd PMA cleared bone graft for the spine.