Cervical Disc Articles & Analysis
6 news found
In 2015, the company’s first-generation bone graft became the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine. ...
” i-FACTOR bone graft has over 10 years of clinical success in Europe and was approved in the U.S. for use in anterior cervical discectomy and fusion (ACDF) procedures in 2015. The drug-device combination product is based on small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease. ...
i-FACTOR bone graft has over 10 years of clinical success in Europe and was approved in the U.S. for use in anterior cervical discectomy and fusion (ACDF) procedures in 2015. The drug-device combination product is based on small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease. ...
Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single-level anterior cervical fusion procedures. “In addition to the commercial launch in Canada, the latest i-FACTOR+ MATRIX generation is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously announced. i-FACTOR+ Matrix is the ...
Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single-level anterior cervical fusion procedures. In 2018, the company enrolled the first patients in an IDE clinical trial, ASPIRE, evaluating the safety and efficacy of its next-generation product, P-15L Peptide Enhanced Bone Graft, for use in patients undergoing TLIF fusion surgery. ...
Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. ...