APPROVED FOR SINGLE-LEVEL ACDF

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iFactor

i-FACTOR® is the first spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide, and the only bone graft FDA approved for single-level anterior cervical discectomy and fusion (ACDF).1-5 Delivering the SAFETY and EFFICACY you require backed by the Level 1 EVIDENCE you demand so that patients can live their healthiest lives.1-8

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Empowering you with a proven spinal bone graft option trusted since 2015.1

Efficacy

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High fusion rates at 1, 2, and 6 years1

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High fusion rates at 1, 2, and 6 years1

  • Demonstrated in a FDA-approved Level 1 premarket approval (PMA) study across 6 years7-9
  • i-FACTOR demonstrated 89.7% fusion at 1 year, 97.3% fusion at 2 years, and 98.6% fusion at 6 years1
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Statistically superior in overall success at 1 and 2 years7,8

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Statistically superior in overall success at 1 and 2 years7,8

  • Overall success is determined by a composite of all four endpoints being met, including fusion, function (NDI), neurological, and safety8
  • Demonstrated in the single-level ACDF PMA study vs local autograft7,8,9

EVIDENCE

Spine icon

Only Class III FDA-approved spinal bone graft for single-level ACDF1,2,6

Spine icon

Only Class III FDA-approved spinal bone graft for single-level ACDF1,2,6

  • Of 350+ spinal bone graft products, i-FACTOR is backed by Level 1 human clinical data from a PMA study published in both Spine and Neurosurgery7-9
  • Patients treated with i-FACTOR in their single-level ACDF reported improvement in their health-related quality of life vs baseline at 12 and 24 months post-surgery. This was statistically non-inferior to those patients treated with local autograft1,8
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Evidence published in esteemed scientific journals

Journal icon

Evidence published in esteemed scientific journals

  • 1 year published in Spine7
  • 2 & 6 year published in Neurosurgery8,9
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Patient population included high-risk patients

Person icon

Patient population included high-risk patients

  • In the pivotal PMA study, 28.5% of i-FACTOR patients were high risk (smokers and/or diabetics)1,2*†

SAFETY

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Safety equivalent to local autograft7-9

Icon of a paper with a shield

Safety equivalent to local autograft7-9

  • No ectopic bone formation was observed in the PMA study1,8‡
  • No increased dysphagia or radiculitis1,8§
  • No incidents of osteolysis1,8§
  • Only grows bone where you need it1,8‡
  • Contains no human tissue or cells1
  • Long-term safety as demonstrated at 6 years9

See Important Safety Information

 

*

Overall, significantly lower fusion success rates were observed in both treatment groups as a result of smoking.

†

i-FACTOR is contraindicated in metabolic or systemic disorders that affect bone or wound healing (ie, uncontrolled diabetes).

‡

No evidence of ectopic bone formation when contained in a bony healing environment in accordance with the IFU.

§

As demonstrated in the single-level ACDF PMA IDE study.

i-FACTOR was rigorously tested in a Level 1 premarket approval (PMA) study.1,7-9

Prospective, randomized, controlled, statistically-powered PMA study

Prospective, randomized, controlled, statistically-powered PMA study

  • i-FACTOR vs local autograft in single-level ACDF (C3-C7) 
  • i-FACTOR study test arm was not mixed with autograft or non-structural allograft 
  • Four primary endpoints: fusion, function (NDI), neurological, safety
FUSION Results over 6 years

FUSION Results over 6 years

  • 88.7% fusion at 1 year
  • 97.3% fusion at 2 years
  • 98.6% fusion at 6 years
28.5% of patients were high-risk

28.5% of patients were high-risk

  • 319 patients total (90 high-risk) 
  • 22 clinical sites 
  • High-risk included smokers and/or diabetics
OVERALL SUCCESS

OVERALL SUCCESS

  • Statistically superior in overall success at 1 and 2 years
  • Overall success was determined by 
a composite of all four primary endpoints 
being met including: fusion, function (NDI), 
neurological, and safety
Cell

i-FACTOR is the only Class III FDA-approved spinal bone graft for single-level ACDF.1,2

See how this proven mechanism works

Ready-to-use off the shelf

Out of 350+ spinal bone grafts available, i-FACTOR is one of two Class III drug devices approved for use in spine surgery and the only one powered by P-15 Peptide.1,6

Flowable and designed for contained spaces.1‡

‡

Approved for 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.

Hand holding an iFactor dosing
Cell

i-FACTOR’s product handling advantages

  • No preparation time – no mixing or hydrating
  • Contains no human tissue or cells – no tissue tracking
  • Radiopaque – easily visualized on x-ray
  • Stored at room temperature – no thawing
  • No freezer required
  • Three-year shelf life

Your patients need results.

You can deliver.7,8,9

Find out more

Description

Catalog #

i-FACTOR Bone Graft, 1.0cc

700-010

i-FACTOR Bone Graft, 2.5cc

700-025

i-FACTOR Bone Graft, 5.0cc

700-050

Additional i-FACTOR resources here.

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Indications and Important Safety Information for i-FACTOR® Peptide Enhanced Bone Graft (Rx Only)

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Indications and Important Safety Information for i-FACTOR® Peptide Enhanced Bone Graft (Rx Only)

Indications

i-FACTOR® Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring, or a PEEK, titanium alloy or PEEK/titanium interbody fusion device cleared by the FDA for use in the cervical spine and with supplemental anterior plate fixation.

Contraindications

i-FACTOR Peptide Enhanced Bone Graft should not be used in situations where there is:

  • An absence of load bearing structural support at the graft site
  • Sensitivity to any components of i-FACTOR Peptide Enhanced Bone Graft
  • Acute or chronic infections, systemic or at the operative site
  • Metabolic or systemic disorders that affect bone or wound healing
  • Compromised renal or hepatic function

Warnings

  • i-FACTOR Peptide Enhanced Bone Graft is designed for single patient use only.
  • Women of childbearing potential should avoid becoming pregnant for one year after being treated with i-FACTOR Peptide Enhanced Bone Graft.
  • The effects of i-FACTOR Peptide Enhanced Bone Graft on nursing women has not been evaluated.
  • The safety and effectiveness of i-FACTOR Peptide Enhanced Bone Graft has not been established:
    • When mixed with any addition components
    • With implants other than allograft rings or FDA cleared PEEK, titanium alloy, or PEEK titanium interbody fusion devices and anterior cervical plates 
    • When applied in anatomic sites other than the cervical spine
    • In patients with pathology at more than one level
    • In patients who are not skeletally mature
    • In patients with hepatic or renal impairment
    • For volumes out of the range of 0.15cc to 4.0cc
    • In patients with metabolic bone disease

Precautions

  • i-FACTOR Peptide Enhanced Bone Graft should only be used by physicians who are experienced with cervical spine fusion.
  • i-FACTOR Peptide Enhanced Bone Graft should only be used in surgical procedures where it can be adequately contained in the allograft ring or FDA cleared interbody fusion device.
  • i-FACTOR Peptide Enhanced Bone Graft is not intended to provide load bearing structural support during the healing process. Use of metallic anterior plate fixation is required to assure stabilization of the construct in all planes.
  • Patients with significant vascular impairment may be at increased risk of non-union.
  • The potential for the use of i-FACTOR Bone Graft to result in an immune response (allergic reaction) has not been established. Immune responses have not been observed in studies using i-FACTOR Bone Graft in animals (sheep) and in humans.

Adverse Events

The most common adverse events that occurred during the IDE clinical study include:

  • Axial pain (nuchal, periscapular, or neck pain)
  • Postoperative radiculopathy/radiculitis
  • Dysphagia

Attention

Reference the Instructions for Use for a complete listing of important Indications and Safety Information.

References:

  1. i-FACTOR US Instructions for Use. Cerapedics.
  2. Cerapedics. Data on file.
  3. Nguyen H, et al. Biochem Biophys Res Commun. 2003;311(1):179-186.
  4. Yang XB, et al. Tissue Eng. 2004;10(7-8):1148-1159.2004;10(7-8):1148-1159.
  5. Liu Q, et al. J Orthop Res. 2012;10:1526.
  6. Abjornson C, et al. Int J Spine Surg. 2018;12(6):757-771.
  7. Arnold PM, et al. Spine. 2016;41(13):1075-1083.
  8. Arnold PM, et al. Neurosurgery. 2018;83(3):377-384.
  9. Arnold PM, et al. Neurosurgery. 2023;92(4):725-733.