I factor bone graftmade of The i-FACTOR Peptide Enhanced Bone Graft represents a significant advancement in spinal fusion procedures, leveraging the power of the P-15 osteogenic cell-binding peptide. This innovative material is designed to facilitate bone formation and fusion, offering a promising alternative to traditional bone grafting methods. Its unique composition and FDA approval for specific applications underscore its role in modern orthopedic and spinal surgery.
At its core, i-FACTOR is a composite bone substitute material. It comprises a P-15 synthetic collagen fragment, which is a biomimetic peptide sequence derived from type I collagen, adsorbed onto an organic bone mineral (ABM) matrix.The study suggested thati-FACTOR marginally reduced costs, had fewer complications, and showed a statistically non-significant reduction in surgical ... This P-15 peptide acts as a potent cell attachment factor, mimicking natural biological processes to encourage osteoblast adhesion and proliferation.P128. Six-year follow-up of i-FACTOR® peptide enhanced ... The material is suspended in a putty form, making it versatile for surgical applicationThe study suggested thati-FACTOR marginally reduced costs, had fewer complications, and showed a statistically non-significant reduction in surgical ....
The P-15 peptide itself is a naturally occurring 15-amino acid sequence that plays a crucial role in cell binding to collagen.P-15 | Cerapedics Corporate By incorporating this peptide, i-FACTOR aims to actively stimulate the growth of bone-forming cells, thereby enhancing the natural bone healing and fusion process. This approach distinguishes it from grafts that rely solely on osteoconductive or osteoinductive properties.
i-FACTOR Peptide Enhanced Bone Graft has received FDA approval for specific uses, primarily in spinal fusion. It is indicated for use in skeletally mature patients for the reconstruction of a degenerated cervical disc at one level, particularly in anterior cervical discectomy and fusion (ACDF) procedures. The FDA approval signifies that i-FACTOR has met rigorous standards for safety and efficacy in these applications.
Clinical studies and follow-up research have demonstrated i-FACTOR's ability to meet FDA-mandated noninferiority success criteria in single-level anterior cervical discectomy and fusioni-FACTOR® Peptide Enhanced Bone Graftis the only biologic bone graft in orthopedics that incorporates. P-15 osteogenic cell binding peptide to stimulate the .... These studies often highlight its safety profile and effectiveness when used by trained surgeons experienced in cervical spine fusion. The graft is approved for use with an allograft bone ring or in conjunction with implants like PEEK or titanium alloy.
One of the key advantages of i-FACTOR is its ability to promote faster bone development compared to some traditional grafting methods.i-FACTOR Research has suggested that i-FACTOR can marginally reduce costs associated with ACDF surgery and may lead to fewer complications. Its cost-effectiveness has been a subject of study, with findings indicating that it can be an economically dominant strategy compared to autografts in ACDF surgery, offering incremental savings over time.
Unlike autografts, which involve harvesting bone from the patient's own body and can lead to donor site morbidity, i-FACTOR is a synthetic, allogeneic material2025年8月5日—Results In all scenarios,i-FACTOR reduced costs within the first year by 1.4% to 2.1%. The savings proved to be incremental over time, .... This eliminates the need for a secondary surgical site for bone procurement, potentially simplifying the surgical procedure and reducing patient recovery time. Furthermore, studies have indicated that i-FACTOR can be a safe and effective alternative to local autologous bone graft in certain spinal fusion procedures.
The i-FACTOR Peptide Enhanced Bone Graft is intended for use by surgeons who are specifically trained in its application and have experience performing cervical spine fusion. Proper surgical technique and adherence to the provided instructions for use are crucial for achieving optimal outcomes. The material's putty form allows for precise placement within the surgical site, ensuring adequate coverage and support for fusion2025年6月23日—Cerapedics Announces FDA Approval of PearlMatrix™ P-15Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator for Lumbar ....
While i-FACTOR has demonstrated favorable clinical outcomes, it is important for surgeons and patients to be aware of the specific indications and contraindications. Its use is generally limited to single-level fusions in skeletally mature patients. As with any surgical implant or graft, potential risks and complications, though generally low, should be discussed between the patient and surgeon.
The success of i-FACTOR has paved the way for further innovation in peptide-enhanced bone graftingSix-Year Follow-up of a Randomized Controlled Trial of i- .... Cerapedics, the developer of i-FACTOR, has also introduced other related products, such as PearlMatrix™ P-15 Peptide Enhanced Bone Graft, which is recognized as a bone growth accelerator for lumbar procedures. These developments indicate a growing trend towards utilizing advanced biomaterials and peptides to optimize bone regeneration and fusion outcomes in orthopedic surgery.Infuse Bone Graftstimulates the growth of bone-forming cells, manufacturing new bone to replace or heal existing bone. Continued research and clinical trials are expected to further elucidate the long-term efficacy and expand the applications of these peptide-enhanced bone graft technologies.
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