I factor bone graftmade of The dominant search intent for "i factor peptide enhanced bone graft" is to understand what this specific bone graft product is, its composition, its approval status, its effectiveness, and its potential benefits, particularly in comparison to other options.i-FACTOR® Peptide Enhanced Bone Graftis the only biologic bone graft in orthopedics that incorporates. P-15 osteogenic cell binding peptide to stimulate the ... There's a clear interest in its unique peptide component (P-15) and its FDA approval for spinal fusion proceduresSix-Year Follow-up of a Randomized Controlled Trial of i- ....
Tier 1 Entities & Phrases:
* i-FACTOR peptide enhanced bone graft (search_keyword)
* P-15 Osteogenic Cell Binding Peptide
* FDA approved
* spinal fusion
* anterior cervical discectomy and fusion (ACDF)
* synthetic peptide osteoconductive bone substitute
* composite bone substitute material
* single-level anterior cervical discectomy fusion
Tier 2 Entities & Phrases:
* Cerapedics (manufacturer)
* skeletally mature patients
* cost-effective
* safety and efficacy
* noninferiority success criteria
* P-15L
* local autologous bone graft
* allograft bone ring
* PEEK, titanium alloy
* bone growth accelerator
* bone stimulant
* OsteoAMP (competitor/related product type)
* PearlMatrixBone Graft (related product)
* ViviGenbone graft (related product)
* MagnetOsbone graft (related product)
Tier 3 Entities & Phrases:
* Medical Miscoding of Spinal Procedures
* Platelet-Rich Fibrin as a Bone Graft Material
* Six-year follow-up (repetitive study reference)
* specific study authors and years (unless crucial for a point)
* PDF links
* Video segments
* Coverage criteria
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The i-FACTOR peptide enhanced bone graft stands out as a significant advancement in spinal fusion surgery, primarily recognized for its innovative use of the P-15 Osteogenic Cell Binding Peptide.P-15 Peptide Enhanced Bone Graft in Transforaminal ... This synthetic bone graft substitute is designed to promote bone fusion by mimicking natural biological processes, offering a unique alternative to traditional grafting materials. Its development and FDA approval have positioned it as a key player in procedures like anterior cervical discectomy and fusion (ACDF), aiming to enhance patient outcomes through a combination of osteoconductivity and cellular binding capabilitiesi-FACTOR.
At its core, the i-FACTOR peptide enhanced bone graft is a composite material.2024年9月24日—i-FACTOR is now approved for single-level anterior cervical discectomy fusion(ACDF) with an allograft bone ring, or in conjunction with a PEEK, titanium alloy ... It features a synthetically produced 15-amino acid polypeptide, known as the P-15 peptide, which is chemically bound to an anorganic bone mineral (ABM) matrix. This P-15 peptide is a biomimetic sequence derived from type-I collagen, the primary structural protein in bone. Its specific function is to act as a potent cell attachment factor, encouraging osteoblasts (bone-forming cells) to adhere to the graft material. Once attached, these cells can then proliferate and differentiate, initiating the natural bone healing cascade. This process is crucial for achieving solid bony fusion, which is the ultimate goal in many spinal surgeries. Unlike grafts that rely solely on inherent growth factors or porous structures, i-FACTOR leverages a targeted peptide sequence to actively recruit and support bone-forming cells, making it an osteoconductive and cell-binding agent.
The i-FACTOR peptide enhanced bone graft has secured FDA approval for specific applications, marking a critical milestone in its clinical adoption. It is indicated for use in skeletally mature patients for the reconstruction of a degenerated cervical disc at one level, typically from C3 downwards. This approval signifies that the graft has met rigorous safety and efficacy standards mandated by the U.2026年1月1日—i-FACTOR (i.e., P-15 peptide bone putty)is a synthetic peptide osteoconductive bone substituteapproved for use in cervical fusion procedures ...S. Food and Drug AdministrationP-15 | Cerapedics Corporate. Studies, including long-term follow-ups, have demonstrated that i-FACTOR has met all four FDA-mandated noninferiority success criteria in single-level anterior cervical discectomy and fusion (ACDF) procedures when used in conjunction with an allograft bone ring or compatible implants like PEEK or titanium alloy. This robust clinical validation underscores its reliability and effectiveness in its approved indications.
Clinical research and real-world application suggest several advantages for the i-FACTOR peptide enhanced bone graft. Its peptide-enhanced nature aims to facilitate a more predictable and robust fusion process compared to some traditional bone graft substitutes. Studies have indicated that in certain patient populations, such as elderly patients, the use of i-FACTOR, often combined with local bone, has resulted in statistically significantly higher fusion rates(PDF) Cost-Effectiveness of Peptide Enhanced Bone Graft i .... Furthermore, investigations into its cost-effectiveness have proposed that i-FACTOR may offer economic benefits, with some analyses showing reduced costs within the first year of use compared to autograft, with incremental savings over time.I-FACTOR™ PEPTIDE ENHANCED BONE GRAFT The graft is also designed to be a safe and effective alternative to local autologous bone graft in specific surgical scenarios, potentially minimizing donor site morbidity associated with harvesting autograftPlatelet-Rich Fibrin as a Bone Graft Material in Oral and Maxillofacial ....
The landscape of bone grafting materials is diverse, and i-FACTOR occupies a distinct nicheCerapedics Announces FDA Approval of PearlMatrix™ P .... Traditional options include autograft (bone harvested from the patient's own body), allograft (bone from a deceased donor), and various synthetic bone graft substitutes. Autograft is often considered the gold standard due to its biological activity but carries the risk of pain and complications at the harvest site. Allograft provides bone tissue without the need for a second surgical site but lacks the inherent osteogenic and cell-binding properties of autograft.ISASS Recommendations and Coverage Criteria for Bone ...
Synthetic substitutes vary widely; some are purely osteoconductive, providing a scaffold for bone growth, while others, like i-FACTOR, incorporate bioactive elements such as peptides to actively stimulate cellular activity. For instance, products like OsteoAMP are allogeneic bone graft substitutes processed to preserve specific growth factorsP-15 | Cerapedics Corporate. Other related products such as PearlMatrixBone Graft and ViviGenbone graft represent different approaches to bone regenerationi-FACTOR® Peptide Enhanced Bone Graftis the only biologic bone graft in orthopedics that incorporates. P-15 osteogenic cell binding peptide to stimulate the .... i-FACTOR's unique selling proposition lies in its P-15 peptide, which directly addresses cell attachment, a critical initial step in the bone healing process. Its classification as a Class III FDA-approved bone graft further distinguishes it, indicating a higher level of regulatory scrutiny and a more significant role in supporting life or preventing impairment.The FDA has approved expanded indications forCerapedics' i-FACTOR P-15 Peptide Enhanced Bone Graft, enhancing its utility in spinal fusion procedures.
The successful application of the i-FACTOR peptide enhanced bone graft is contingent on proper surgical technique and surgeon trainingCost-Effectiveness of Peptide Enhanced Bone Graft i- .... It is intended for use by surgeons who are experienced in spinal fusion procedures and have received specific training on the product's handling and implantation. The graft may be used in conjunction with bone void fillers, allograft bone rings, or interbody devices made from materials like PEEK or titanium alloy, depending on the specific surgical approach and surgeon's preferenceCerapedics' i-FACTOR P-15 Peptide Enhanced Bone Graft .... As with any medical device, adherence to the manufacturer's instructions for use and understanding the patient selection criteria are paramount to achieving optimal outcomes and ensuring patient safety.2025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, ...
In conclusion, the i-FACTOR peptide enhanced bone graft represents a scientifically advanced solution for spinal fusion. Its foundation in the P-15 peptide's cell-binding capabilities, coupled with FDA approval for key cervical spine procedures, offers surgeons a valuable tool for promoting bone fusion.i-FACTOR Peptide Enhanced Bone Graftshould only be used by doctors who are trained in using itand have experience performing cervical spine fusion. Page 8. 8. While ongoing research and clinical experience continue to refine its role, i-FACTOR has demonstrably established itself as an effective and potentially cost-beneficial option in the surgical armamentarium.
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