Patients with 1-level DS achieved estimated fusion rates of 40 percent (29/72) with i-FACTOR Peptide Enhanced Bone Graft versus 21 percent (17/80) with allograft. Results demonstrated a 50 percent fusion rate (63/126) using i-FACTOR Peptide Enhanced Bone Graft compared to a 20 percent fusion rate (23/114) using allograft at one-year postoperative follow-up. In the single center, double-blind, randomized IVANOS study, 98 patients (240 treated levels) age 60 and older with lumbar spinal stenosis (LSS) and concomitant degenerative olisthesis (DS) were treated with non-instrumented lumbar posterolateral spine surgery and received either i-FACTOR Peptide Enhanced Bone Graft or allograft. In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a PMA in 2015 only for use in single level anterior cervical fusion procedures.
i-FACTOR Peptide Enhanced Bone Graft was approved in the European Union in 2008 and in Australia in 2010 for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). In spinal fusion procedures, surgeons use bone graft to join and stabilize vertebrae. I-FACTOR Peptide Enhanced Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation. Results were presented by Mikkel O Andersen, MD, from the Sector for Spine Surgery and Research at Middelfart Hospital in Denmark, at the 7 th Annual Global Spine Congress held May 2-5 in Singapore. WESTMINSTER, Colo., /PRNewswire/ - Cerapedics, a privately-held orthobiologics company, today announced results from the IVANOS study evaluating i-FACTOR™ Peptide Enhanced Bone Graft in lumbar posterolateral spine surgery.
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