Studies show that use of pulsed electromagnetic field (PEMF) treatment after anterior cervical discectomy and fusion (ACDF) significantly increased the fusion rate vs. control at 6 and 12 months, for participants at risk for pseudoarthrosis.
The evaluations used historical data from Orthofix’s 2014 investigational device exemption premarket approval study of 323 patients conducted plus data from a new multicenter, retrospective cohort study of 274 patients. In the latter, participants were required to have one or more risk factors for pseudoarthrosis (failure to fuse). All were treated with PEMF following ACDF.
Cervical-Stim is FDA-approved for use as an adjunct to cervical spinal fusion and is the only bone growth therapy device approved by FDA as a noninvasive, adjunctive treatment option for cervical fusion in high risk patients.
Source: Orthofix International N.V.