Providence Medical Technology Releases Two-Year Facet System Study Data
Lafayette, Calif.-based Providence Medical Technology Inc. has released two-year data on patients treated with its DTRAX facet system. The data represents follow-up to the one-year results published earlier in 2013 in the Journal of Neurosurgery: Spine.
The DTRAX facet system is a sterile, self-contained, single-use kit containing all of the tools and implants needed to perform a single level vertebral surgery. The system includes a proprietary, expandable, titanium implant that is used to provide indirect decompression and fusion of cervical facets. The system received the CE mark for marketing in the European Union in July 2011 and is indicated for the treatment of cervical radiculopathy. According to Providence, the DTRAX implant can be used with adjunctive graft material, including demineralized bone matrix or other injectable biologics.
The DTRAX facet system implant consists of two titanium components: a 10mm long and 2.2 mm diameter titanium screw with tapered
threaded shaft and an expandable washer consisting of two titanium base plates connected at the distal tip with an interlocking weld. Both components are held preassembled by a delivery tool with the screw partially engaging the threads of the expandable washer. As the screw is advanced into the closed washer, the base plates are designed to separate causing the posteriorly directed teeth to grip the facet joint. There is a half slot at the distal end of the washer and corresponding interruption in the distal screw thread that lock together to prevent screw back-out.
“Providence invested in clinical evidence early in the company’s history,” said Jeff Smith, co-founder and CEO of Providence. “These two-year clinical outcomes demonstrate the durable patient benefit of the DTRAX Facet System. “We are encouraged by this evidence supporting the safety and efficacy of indirect decompression and stabilization for the treatment of cervical radiculopathy with the DTRAX facet system. This is especially exciting given our recent announcement of the U.S. market availability of the PMT cervical cage.”
The company released the PMT cervical cage earlier this month.
According to the two-year follow up data, 53 of the 60 previously reported patients were available for follow-up. NDI (neck disability index), VAS (visual analogue scale for pain), and SF-12v2 (a health survey conducted by Quality Metric) scores were significantly improved at two years. There were reportedly no significant changes in treated level and overall cervical lordosis compared to the baseline. Anterior, middle, and posterior disc height decreased, of which only posterior disc height was significant. There was no device breakage, device back-out, or surgical re-interventions.
“The initial response from U.S. surgeons was very positive and we anticipate significant adoption in 2014,” said Smith. “Just as important, we intend to continue investing significantly in clinical evidence during the initial stages of our launch to validate and expand upon the data already available.”