Aurora Spine Corporation has received Australian Therapeutic Goods Administration (TGA) clearance for the ZIP Ultra™ Interspinous Fusion System.
Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.
Aurora Spine’s ZIP is a minimally invasive (MIS) spinal fixation device for spinal fusion and was developed as an alternative to the pedicle screw systems prevalent in the market. The device gained CE mark approval last July (2013) as we reported here. Now it has TGA clearance and is listed on the Australian Register of Therapeutic Goods (ARTG #219670) website.
The Aurora Spine Zip MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine Zip™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
“The receipt of the Australian Therapeutic Goods Administration (TGA) clearance is a significant step forward in Aurora Spine’s expansion into the global Minimally Invasive Spinal Device market,” says Brent Johnston, Chief Commercialization Officer of Aurora Spine. “Aurora Spine will continue to strive to bring improved fusion technology to patients and position itself as a leader in spinal technology.”
Source: Aurora Spine, Market Wired