Paradigm Spine, LLC Announces Publication Of 5-Year Long-Term Results Of Level 1 Data For coflex Interlaminar Stabilization Compared To Fusion
NEW YORK, Jan. 27, 2016 /PRNewswire/ -- Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis announces publication on January 26, 2016 by Michael Musacchio, M.D., et al of "Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial" 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://dx.doi.org/10.14444/3006.
These data convincingly demonstrate the long-term sustained therapeutic effect of coflex® Interlaminar Stabilization® ("ILS") for patients with lumbar spinal stenosis, as compared against fusion. With 322 patients enrolled and randomized in this study, and a high follow-up rate of over 90% at five years, the authors concluded, "The results of this study with 5-year follow-up support that decompression and ILS is an effective and sustainable treatment option for moderate to severe spinal stenosis and not an inevitable precursor to fusion. ILS after decompression produces outcomes similar or superior to fusion with pedicle screws. One and two levels yield equally good results compared to fusion. Two level D+ILS procedures had a significantly lower rate of revision than fusion procedures. Reductions in VAS back and leg pain were significant and sustainable in both groups."
As this landmark study definitively establishes long-term evidence, in addition to the wealth of previously published peer-review 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®, particularly when compared against fusion."
Hallett Mathews, M.D., MBA, EVP & CMO of Paradigm Spine, LLC has confidence that patients, surgeons, and payors 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 lumbar spinal stenosis. The long-term results discussed in this landmark article provide definitive Level 1 evidence that fusion stabilization should no longer be the only stabilization consideration for spinal stenosis patients. Surgeons have never been able to decompress lumbar spinal stenosis and stabilize, without some sort of fusion procedure. This is a great day for patients providing an earlier return to daily activities with sustainable therapy. 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.
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SOURCE Paradigm Spine, LLC
