Providence Medical Technology, a developer of cervical spine technology, has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its DTRAX line of instruments and implants used in tissue-sparing posterior cervical fusion.
The TGA approval covers the GL-DTRAX Spinal System, the GL-DTRAX Cervical Cage-T System, the GL-DTRAX Cervical Cage-B, the GL-DTRAX Expandable Cage, and the GL-DTRAX Bone Screw.
Providence’s DTRAX line of devices and instruments are designed to increase procedural efficiency, improve clinical outcomes, minimise complications, and reduce recovery times. Tissue-sparing posterior cervical fusion with intervertebral cages are intended to offer advantages over traditional posterior fusion techniques.
According to a company release, the products have seen continued, rapid adoption by spine surgeons, hospitals, and ambulatory surgery centres since their introduction. To date, over 7,000 DTRAX procedures have been performed worldwide.
The company plans to submit products to the Australian Prostheses List in August 2017 for inclusion in early 2018. This list catalogues surgically-implanted prostheses and other medical devices for which private health insurers must pay benefits under certain conditions.
“We are excited to deliver our innovative spinal technology to the Australian market and provide patients with less disruptive options for cervical spine surgery,” says Michael Scott, vice president of International with Providence. “Australia represents an important, strategic market as it boasts a robust healthcare system, offers established reimbursement, and has a history of embracing innovative treatments for spine surgery.”