Cervical Fusion Articles & Analysis
7 news found
The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a statistically significantly higher fusion rate compared to allograft plus local bone. “In Scandinavia, surgeons often consider performing non-instrumented fusion when there is instability in elderly patients, but allograft bone has notoriously low ...
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. ...
Cerapedics Cerapedics developed the i-Factor peptide enhanced bone graft that is already FDA approved for use in cervical fusion and Cerapedics is pursuing a lumbar fusion indication. ...
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 ...
” “In addition to an anticipated commercial launch in Canada this October, the technology is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously announced. i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE.,” said Jeffrey Marx, Ph.D., President and Chief Operating Officer of ...
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. ...
Applying these technologies to an entire spine portfolio offers us the potential to offer patients better fixation after fusion surgeries.” – Douglas Pahl, MD, Todd Bonvallet, MD, The Hughston Clinic, Columbus, GA “The FortiCore scaffold has performed well for my patients in lumbar and cervical fusions, providing a large ...
ByNanovis