Westminster, Colorado-based Cerapedics, Inc. has announced results from the IVANOS study evaluating the company’s i-FACTOR Peptide Enhanced Bone Graft in lumbar posterolateral spine surgery.
Results were presented by Mikkel Andersen, M.D., from the Sector for Spine Surgery and Research at Middelfart Hospital in Denmark, at the 7th Annual Global Spine Congress held May 2-5 in Singapore.
According to the company, “i-FACTOR Peptide Enhanced Bone Graft is based on a proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation.”
“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 spondolisthesis (DS) were treated with non-instrumented lumbar posterolateral spine surgery and received either i-FACTOR Peptide Enhanced Bone Graft or allograft.”
“Results demonstrated a 50% fusion rate (63/126) using i-FACTOR Peptide Enhanced Bone Graft compared to a 20% fusion rate (23/114) using allograft at one-year postoperative follow-up.”
“Patients with 1-level DS achieved estimated fusion rates of 40% (29/72) with i-FACTOR Peptide Enhanced Bone Graft versus 21% (17/80) with allograft. Patients with 2-level DS achieved estimated fusion rates of 63% (34/54) with i-FACTOR Peptide Enhanced Bone Graft versus 18%(6/34) with allograft.”
Mikkel Andersen, M.D. told OTW, “In Denmark, orthopedic surgeons typically use non-instrumented spinal fusion in elderly patients with degenerative disc diseases and current products often don’t yield optimal fusion rates. These new data are exciting because they show i-FACTOR Bone Graft in combination with local harvested bone results in superior fusion rates compared to allograft.”
”While some surgeons may be surprised by the 50% fusion rate with i-FACTOR Bone Graft at one-year postoperative follow-up, it is important to note that this is a significantly superior outcome compared to the standard bone bank allograft often used, which resulted in an approximately 20% fusion rate in this study.”
“The elderly patient population presents a challenging environment to obtain fusion due to their mechanical instability and poor bone healing potential, often resulting in lower fusion rates. i-FACTOR Bone Graft may offer a solution to this problem.”
”Surgeons are coming under increased pressure to reduce costs and get it right the first time as we continue to strive towards better outcomes for patients. With an aging population it is important we (orthopedic surgeons) use the most advanced technology available in order to reduce the risk of pseudarthrosis. i-FACTOR Bone Graft in combination with local harvested bone seems to be an easy-to-use, off-the-shelf product increasing fusion rates in spine surgery.”
“In spinal fusion procedures, surgeons use bone graft to join and stabilize vertebrae. 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 the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a PMA [premarket approval] in 2015 only for use in single level anterior cervical fusion procedures.”
