Healthcare Industry News:  Spinal Stenosis 

Devices Orthopaedic Neurosurgery

 News Release - May 12, 2015

Paradigm Spine, LLC Announces The Publication Of Long-term Results Of Level 1 Data For coflex(R) Interlaminar Stabilization(R)

NEW YORK, May 12, 2015 -- (Healthcare Sales & Marketing Network) -- Paradigm Spine, LLC, a leader in providing solutions for the treatment of advanced degenerative lumbar Spinal Stenosis announces publication on May 11, 2015 by Hyun Bae, M.D., et al of "Therapeutic sustainability and durability of coflex® Interlaminar Stabilization after decompression for lumbar Spinal Stenosis: a four year assessment" in the International Journal of Spine Surgery, a high quality peer review journal published on behalf of the International Society for the Advancement of Spine Surgery. Please find a link to the article here: http://ijssurgery.com/10.14444/2015.

These data convincingly demonstrate the long-term sustained therapeutic effect of coflex® Interlaminar Stabilization® for patients with lumbar Spinal Stenosis. With 344 patients enrolled and randomized in this study, and a high follow-up rate of over 85% at four years in both treatment groups, the authors concluded, "This study demonstrates that coflex® Interlaminar Stabilization is associated with improved clinical, safety, and radiographic outcomes at 48 months post-op when compared to fusion in the studied patient population."

As this study continues to add to the wealth of published literature on coflex® Interlaminar Stabilization® worldwide, Marc Viscogliosi, Chairman and CEO of Paradigm Spine, LLC comments, "All interested stakeholders, including patients, physicians, payors, providers and policy-makers, are critically focused on long-term data and sustainability of therapeutic treatment effects and we are pleased to see this study provide definitive long-term evidence of the positive clinical attributes of coflex® Interlaminar Stabilization®."

Hallett Mathews, M.D., MBA, EVP & CMO of Paradigm Spine, LLC has confidence that both patients and surgeons will be positively impressed with the long-term durability and sustainability provided with the coflex® device. "Surgeons appreciate the effectiveness of providing stabilization after decompression for advanced degenerative lumbar Spinal Stenosis. The long-term results discussed in this article provide Level 1 evidence that fusion stabilization may no longer be the gold standard for Spinal Stenosis patients. We anticipate that the payor community will embrace these findings as further evidence of comparative effectiveness of coflex® Interlaminar Stabilization® in providing durable and sustained therapeutic benefits for Spinal Stenosis patients, when compared against fusion."

About Paradigm Spine, LLC

Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of Spinal Stenosis. The Company's signature product is the coflex® Interlaminar Stabilization® device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.


Source: Paradigm Spine

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Please address inquiries directly to the issuing company.



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