Cerapedics wins FDA nod for I-Factor cervical bone graft

Cerapedics said yesterday 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. “This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration. It is the culmination of years of seamless cooperation with our clinical investigators to support PMA approval. With our transition to a commercial stage company, all of us at Cerapedics look forward to bringing an important new biologic bone graft option, the only backed by significant level-1 clinical evidence, to surgeons and patients across the U.S.,”  COO & prez Jeffrey Marx said in a press release. The PMA approval was supported by data from a pivotal clinical trial pitting the I-Factor bone graft against an autograft in ACDF procedures.  The study reported the I-Factor graft met 4 pre-specified endpoints related to fusion rate, NDI score, neurological outcomes and safety success, the company said. Data from the trial reported a 69% success rate in all 4 primary outcomes for the I-Factor versus 57% for the autograft, the company said. “We are extremely pleased and excited about the FDA’s approval of I-Factor bone graft for cervical sp...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Spinal Cerapedics Inc. Source Type: news