FDA Expands Indications for Cerapedics' i-FACTOR Bone Graft in Cervical Spinal Fusion
核心洞察
The FDA has approved expanded indications for Cerapedics (搜索)' i-FACTOR P-15 Peptide Enhanced Bone Graft (搜索), enhancing its utility in spinal fusion procedures.
i-FACTOR is now approved for single-level ACDF with an allograft bone ring or with PEEK or titanium interbody devices, alongside anterior plate fixation.
This expansion underscores Cerapedics (搜索)' commitment to evidence-based bone grafting, providing surgeons with a proven and safe option for spinal fusion.
Cerapedics (搜索) Inc. announced FDA approval for expanded indications for its i-FACTOR P-15 Peptide Enhanced Bone Graft (搜索), a significant advancement in bone grafting solutions for spinal fusion. The approval allows i-FACTOR to be used in single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or in conjunction with a PEEK, titanium alloy, or PEEK/titanium fusion interbody device cleared by the FDA for use in the cervical spine, and with supplemental anterior plate fixation.
This expansion broadens the applicability of i-FACTOR, a Class III FDA-approved bone graft, which has been available in the U.S. since 2015. The approval is based on a premarket approval (PMA) investigational device exemption (IDE) study, reflecting Cerapedics (搜索)' dedication to investing in evidence that supports clinical practice.
Clinical Significance
Anterior cervical discectomy fusion (ACDF) is a surgical procedure performed to alleviate pain resulting from conditions such as degenerative disc disease (搜索). The procedure involves removing a damaged disc and fusing the adjacent vertebral bones to stabilize the spine and decompress the spinal cord. Bone grafts are essential for achieving fusion, facilitating bone growth between the vertebrae over time.
In 2023, approximately 465,000 spinal fusion cases in the U.S. utilized a bone graft replacement, highlighting the importance of effective bone grafting solutions. The expanded indications for i-FACTOR provide surgeons with a clinically proven option backed by Level 1 human clinical data published in Spine and Neurosurgery.
i-FACTOR P-15 Peptide Enhanced Bone Graft
i-FACTOR is powered by P-15 Osteogenic Cell Binding Peptide, which offers a precise bone-building mechanism. It is indicated for skeletally mature patients requiring reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7. The bone graft has a demonstrated safety profile, comparable to local autograft in single-level ACDF, with statistical superiority in overall success at one and two years.
Valeska Schroeder, CEO of Cerapedics (搜索), stated, "This label expansion approval is part of our deep commitment to bring scientific rigor to bone grafting so surgeons and the patients they treat have access to products with proven safety, efficacy and evidence. We are proud to have FDA approval for the safe and effective use of i-FACTOR in PEEK and titanium cages."
Cerapedics' Commitment
Cerapedics (搜索) aims to redefine the standard of care for bone repair, focusing on faster and higher rates of bone healing without compromising safety. The company's products are used in over four million spine, orthopedics, trauma, and interventional procedures annually worldwide.