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| [January 18, 2013] |
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Providence Medical Technology Announces Publication of 1-Year Follow-Up Data on DTRAX® Facet System
SAN FRANCISCO --(Business Wire)--
Providence
Medical Technology, Inc. today announced the publication of the
first peer-reviewed clinical paper describing the outcomes of the DTRAX
Facet Screw System.
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:
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Sixty (60) patients followed for 1 year
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Significant improvements in pain, disability, and function (VAS, NDI,
SF-12)
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93% incidence of fusion through the facets, confirmed by CT scans
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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 (News - Alert),
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."
About Providence
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.

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