Cerapedics, Inc announced results of a prospective, randomized, controlled trial of its i-FACTOR™ biologic bone graft for patients undergoing posterior lumbar interbody fusion (PLIF) spine procedures. The trial, which was conducted in Europe, was designed to evaluate the safety and efficacy of Cerapedics’ novel i-FACTOR biologic bone graft compared to autologous bone graft. At both 6 and 12 months, i-FACTOR showed superior outcomes to autologous both graft. At 6 months, the radiological fusion rate was 97.7% for patients treated with i-FACTOR compared to 59.1% for patients treated with autograft (p < 0.01). At 12 months, the radiological fusion rate was 97.8% for patients treated with i-FACTOR compared to 82.2% for patients treated with autograft (p < 0.01). i-FACTOR received its CE Mark (European regulatory approval) in 2008 and has been used in more than 3500 surgeries worldwide since that time. Currently, iFACTOR is being evaluated in the United States (FDA) as part of an Investigational Device Exemption (IDE) Clinical Study in the cervical spine. Cerapedics is a medical device company focused on bone repair and based in Westminster, Colorado.
The full press release is available here.
