RTI Surgical enrolls first patient in 3D-printed spinal fusion device study
RTI Surgical (NASDAQ:RTIX) has enrolled the first patient in a clinical trial testing the safety and performance of its Fortilink interbody fusion device.
Fortilink is designed to promote spinal fusion after surgery while maintaining the mechanical properties of bone. The device is manufactured using the TETRAfuse 3D-printing technology developed by Oxford Performance Materials, for which RTI has an exclusive license for spinal applications in the U.S.
The study’s primary objective is to assess radiographic evidence of cervical and lumbar fusion in adult subjects with degenerative disc disease, in addition to pain reduction and procedural and long-term performance. RTI expects enrollment to be complete in early 2020 and plans to evaluate 150 patients at up to 20 sites in the U.S. over the next three-to-four years.