“Publication of this study is an important milestone for our company. We made early investments in clinical evidence and are pleased to share these positive results. The significant and sustained patient benefit demonstrated in the study supports our efforts to offer patients and surgeons minimally invasive alternatives to open surgery.”
Published online by the Journal of Neurosurgery: Spine on January 18, 2013, the paper’s authors include Bruce McCormack, M.D., Sigurd Berven, M.D., and Edward Eyster, M.D., all from San Francisco, and Rafael Bundoc, M.D., Mario Ver, M.D., and Jose Manuel Ignacio, from Manila, Philippines. The manuscript is titled “Percutaneous Posterior Cervical Fusion with DTRAX Facet System for Single Level Radiculopathy - Results in 60 Patients” and can be found at: http://bit.ly/10EzlvG
Highlights from the study include:
- Sixty (60) patients followed for 1 year
- Significant improvements in pain, disability, and function (VAS, NDI, SF-12)
- 93% incidence of fusion through the facets, confirmed by CT scans
- No significant change in overall cervical lordosis
- No reoperations or device related serious adverse events (SAEs)
“This dataset covers the initial clinical experience with the DTRAX Facet Screw System,” commented Providence co-founder Dr. McCormack. “The DTRAX investigators were encouraged by the rapid improvement in symptoms and are pleased with the sustained benefit at 1-year follow-up. The results suggest that in some patients DTRAX could provide a safe and minimally invasive alternative to anterior reconstructive surgery.”
The DTRAX Facet Screw System is a sterile, single-use kit containing all the tools and implants needed to perform a single-level surgery. The system includes a proprietary expandable titanium implant that distracts the cervical facets to provide indirect decompression and stabilization of the spine.
The DTRAX Facet Screw System received a CE Mark in July 2011 and is indicated for the treatment of cervical radiculopathy. The implant can be used with adjunctive graft material, including demineralized bone matrix (DBM) or other injectable biologics.
Providence Medical Technology’s Chief Executive Officer, Jeff Smith, commented, “Publication of this study is an important milestone for our company. We made early investments in clinical evidence and are pleased to share these positive results. The significant and sustained patient benefit demonstrated in the study supports our efforts to offer patients and surgeons minimally invasive alternatives to open surgery.”
Providence Medical Technology is a privately-held medical device company developing minimally invasive solutions addressing the $1 billion worldwide cervical spine market. We are commercializing the DTRAX platform of minimally invasive posterior cervical implants and instruments to treat cervical degenerative disc disease through indirect decompression and stabilization.