Aurora has announced that its minimally invasive interspinous fusion system, the Zip, has received FDA approval. The system was developed as an alternative to pedicle screw systems and, after receiving CE mark approval, has already been used in 40 surgeries across Europe.
According to a press release, the Zip features articulating bone anchors, a one-step locking mechanism with no set screw and a large graft space designed for biologic material. It is designed for stabilisation during T1-S1 lumbar fusion procedures, specifically for the treatment of degenerative disc disease, spondylolisthesis, spinal tumours and trauma. It is available in various sizes to accommodate different patient anatomy.
“Receipt of FDA 510(k) clearance for our Zip minimally invasive interspinous fusion system is a key milestone for Aurora Spine as it allows us to launch the product in the US market. This achievement is a testament to the ongoing dedication and perseverance of our team,” said Trent J Northcutt, president and chief executive officer of Aurora Spine. “I am delighted we have obtained FDA clearance, especially given the overwhelming response for the Zip device in Europe.”