Approval underscores Cerapedics’ dedication to investing in proof that brings scientific rigor to bone grafting for spinal fusion.
WESTMINSTER, Colo., Sept. 24, 2024 /PRNewswire/ — Cerapedics Inc., a worldwide, commercial-stage orthopedics firm devoted to redefining the usual of take care of bone restore, immediately introduced the U.S. Food and Drug Administration (FDA) approval for an growth to the indications to be used and labeling for i-FACTOR P-15 Peptide Enhanced Bone Graft. With this label growth, i-FACTOR is now authorized for single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or along side a PEEK, titanium alloy or PEEK/titanium fusion interbody system cleared by the FDA to be used within the cervical spine, and with supplemental anterior plate fixation.
The premarket approval (PMA) investigational system exemption (IDE) research for i-FACTOR was designed in 2005, utilizing the gold commonplace for ACDF procedures at the moment – an allograft ring. The apply of medication has advanced within the subsequent years, and this indication growth underscores Cerapedics’ dedication to put money into proof that helps scientific apply and meets the wants of our doctor prospects. i-FACTOR can now be used with most interbody cages available on the market offering confirmed security and fusion efficacy by human scientific information.
“This label growth approval is a part of our deep dedication to convey scientific rigor to bone grafting so surgeons and the sufferers they deal with have entry to merchandise with confirmed security, efficacy and proof,” stated Valeska Schroeder, Chief Government Officer of Cerapedics. “i-FACTOR has been a trusted selection in bone graft choice in the USA since 2015 as the one bone graft substitute FDA-approved for single-level ACDF procedures with a premarket approval based mostly on a Degree 1 human scientific trial. We’re proud to have FDA approval for the secure and efficient use of i-FACTOR in PEEK and titanium cages.”
ACDF is a surgical process to scale back or remove ache due to points within the neck like degenerative disc illness by eradicating a broken disc after which uniting (fusing) the spinal vertebral bones above and beneath the broken disc to create spinal stability together with decompression of the spine. The fusion is achieved utilizing a bone graft, which over time, grows along with the vertebrae to kind one bone. In 2023, there have been an estimated 465,000 spinal fusion instances that used a bone graft substitute within the U.S.1
About i-FACTOR P-15 Peptide Enhanced Bone Graft
i-FACTOR is a Class III FDA authorized bone graft backed by rigorous Degree 1 human scientific information from an IDE research printed in Backbone and Neurosurgery. It’s the solely spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide, with a exact bone-building mechanism.* i-FACTOR has a demonstrated security profile and is as secure as native autograft in single-level ACDF with confirmed statistical superiority in general success at one and two years.**
i-FACTOR Peptide Enhanced Bone Graft is indicated to be used in skeletally mature sufferers for reconstruction of a degenerated cervical disc at one degree from C3-C4 to C6-C7. i-FACTOR Peptide Enhanced Bone Graft have to be used inside an allograft bone ring, or along side a PEEK, titanium alloy or PEEK/titanium fusion interbody system cleared by the FDA to be used within the cervical spine, and with supplemental anterior plate fixation.
For extra data, full description of the indication to be used, contraindications, security warnings, and many others. about i-FACTOR, please go to our web site.
* Floor-bound mechanism of motion
** General success is outlined as all 4 endpoints being met together with: Fusion, Operate (NDI), Neurological, Security as demonstrated within the single-level ACDF PMA
About Cerapedics
Cerapedics is a worldwide, commercial-stage orthopedics firm that aspires to redefine the usual of take care of bone restore, therapeutic bones sooner and at increased charges, with out compromising security, in order that sufferers can reside their healthiest lives. Bone grafts, together with Cerapedics’ merchandise, are utilized in over 4 million annual spine, orthopedics, trauma, and interventional procedures worldwide. Cerapedics is headquartered in Westminster, CO.
For extra data, go to us at www.cerapedics.com.
Media contact: FleishmanHillard
fh-cerapedics@fleishman.com
1 Clarivate | Determination Assets Group. Bone Graft Substitutes. December 2022.
SOURCE Cerapedics Inc.
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