SAN FRANCISCO--(EON: Enhanced Online News)--Providence Medical Technology, Inc. (PMT) today announced that two-year follow-up data on patients treated with the DTRAX Facet System will be available in the electronic poster session at the Congress of Neurological Surgeons (CNS) Annual Meeting in San Francisco, October 19-23. This data represents follow-up to the one-year results published earlier in 2013 in the Journal of Neurosurgery: Spine.
“The initial response from U.S. surgeons was very positive and we anticipate significant adoption in 2014. 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.”
“Providence invested in clinical evidence early in the company’s history,” commented Jeff Smith, co-founder and Chief Executive Officer of Providence Medical Technology. “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.”
Authors on the poster are Bruce M. McCormack, MD; Rafael Bundoc, MD; Mario Ver, MD; Jose Manuel Ignacio, MD; Sigurd Berven, MD, and Edward F. Eyster, MD. A manuscript describing the full two-year data set has been submitted for publication. Select data from the results section of the poster states:
“Fifty-three of the 60 previously reported patients were available for follow-up. NDI, VAS, and SF-12v2 scores were significantly improved at two years. There were no significant changes in treated level and overall cervical lordosis compared to 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.”
“We are very excited about the CNS conference and the opportunity to build on the momentum of our U.S. product launch initiated at the NASS (North American Spine Society) conference earlier this month,” said Mr. Smith. “The initial response from U.S. surgeons was very positive and we anticipate significant adoption in 2014. 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.”
Providence Medical Technology is a privately held medical device company developing minimally invasive solutions addressing the $1 billion worldwide cervical fusion market. The company is commercializing the DTRAX platform of cervical devices, which are used to provide indirect decompression and fusion in patients suffering from cervical radiculopathy secondary to degenerative disc disease.