A review of 2-year follow-up data from an FDA Investigational Device Exemption (IDE) clinical trial of Cerapedics' i-FACTOR™ Peptide Enhanced Bone Graft indicated its statistical superiority in overall clinical success to autograft in anterior cervical discectomy and fusion (ACDF).
At two years, analysis of combined endpoints for overall success demonstrated 70% success for patients receiving i-FACTOR vs. 56% for those receiving autograft.
i-FACTOR received FDA Premarket Approval in 2015 for use in ACDF. This represented the first approval of bone graft for use in the cervical spine and the second PMA-approved bone graft in the spine, following Medtronic's INFUSE.
Sources: Cerapedics; ORTHOWORLD Inc.