Australian Regulators Approve Providence Medical’s Tissue-Sparing Cervical Fusion Products

Providence Medical Technology Inc., 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 GL-DTRAX Spinal System, GL-DTRAX Cervical Cage-T System, GL-DTRAX Cervical Cage-B, GL-DTRAX Expandable Cage, and GL-DTRAX Bone Screw. Providence plans to submit products to the Prostheses List in August 2017 for inclusion in early 2018.
 
“We are excited to deliver our innovative spinal technology to the Australian market and provide patients with less disruptive options for cervical spine surgery,” said Michael Scott, vice president of International with Providence. “Australiarepresents 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.”
 
Providence’s DTRAX line of devices and instruments are designed to increase procedural efficiency, improve clinical outcomes, minimize complications, and reduce recovery times. Tissue-sparing posterior cervical fusion with intervertebral cages offers distinct advantages over traditional posterior fusion techniques. The products have seen continued, rapid adoption by spine surgeons, hospitals, and ambulatory surgery centers since their introduction and, to date, more than 7,000 procedures have been performed worldwide.
 
Providence Medical Technology is a privately-held developer of solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX Spinal Instrumentation System, CAVUX intervertebral implants, and the ALLY line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance.