Medtronic launched a long-term global clinical study to collect prospective data on INFUSE® bone graft in posterolateral (PLF) and transforaminal lumbar interbody fusion (TLIF) procedures.
B.O.N.E (BMP Outcomes and New Evidence in PLF and TLIF Procedures) is a multi-center, 10-year program enrolling 550-700 patients at up to 50 sites between the Pilot and Pivotal studies of both procedures. The PLF pilot of ~125 patients will be followed by a TLIF Pilot study in 2018. If successful, pilot studies would be followed by the larger pivotal study.
Medtronic seeks to generate data to expand indications and provide additional options to treat spinal patients.