i-Factor and autograft groups demonstrated significant postsurgical improvement and high fusion rates. 11025 Dover St Unit 1600 Westminster CO 80021-5574: For Additional Information Contact: Rebecca Helpert 30. I-Factor has met all four FDA mandated noninferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for cervical radiculopathy. Class 3 Device Recall iFACTOR Peptide Enhanced Bone Graft Putty: Date Initiated by Firm: April 14, 2022: Create Date: May 10, 2022: Recall Status 1: Open 3, Classified: Recall Number: Z-1056-2022. A high proportion of patients reported good or excellent Odom outcomes (81.4% in both groups). Download your FREE full study guide summary below Complete your details below to receive your FREE full summary PDF guide of this study Purchase the Full PLF Study. bone grafts that enhance and accelerate bone growth in a variety of orthopaedic procedures. Improvements in VAS pain and SF-36v2 scores were clinically relevant and similar between the groups. Randomised double-blind clinical trial of i-FACTOR Peptide Enhanced Bone Graft versus Bone Bank Allograft in non-instrumented lumbar fusion surgery. Overall success rate consisting of fusion, NDI, Neurological Success and Safety Success was higher in i-Factor subjects than in autograft subjects (68.75% and 56.94%, respectively, P = 0.0382). There was no difference in the rate of adverse events (83.64% and 82.47% in the i-Factor and autograft groups, respectively, P = 0.8814). Among 400+ spinal bone grafts on the market, spine surgeons can feel confident in choosing i-FACTOR. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months.Īt 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P < 0.0001), and high Neurological Success rate (93.71% and 93.01%, respectively, noninferiority P < 0.0001). Cerapedics is an advanced orthobiologics company with i-FACTOR® Peptide Enhanced Bone Graft. Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications. ![]() The companys technology is focused on developing and commercializing novel osteobiologic products that incorporate a small peptide as an attachment. I-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. Developer of ortho-biological technology intended to provide bone graft substitute for use in spinal fusion surgery and other orthopedic procedures. The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial. Cerapedics i-Factor Peptide Enhanced Bone Graft is likely to hit the market sooner than expected, for the company just announced that an advisory committee.
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