FDA Approves 'IDE' Clinical Trial of Paradigm Spine's Coflex(TM) Functionally Dynamic Interspinous Implant Study will involve 460 patients over 4 years



    NEW YORK, May 9 /PRNewswire/ -- Paradigm Spine, LLC ("Paradigm")
 announced that it has received an Investigational Device Exemption ("IDE")
 from the Food and Drug Administration ("FDA"), allowing Paradigm to begin
 clinical trials for the coflex(TM) device, a functionally dynamic
 interspinous implant. The study will involve 460 patients with lumbar
 spinal stenosis at up to 20 sites in a prospective randomized controlled
 study, comparing the coflex(TM) device with pedicle-screw fusion, the
 current standard of care.
     The coflex(TM) device is a U-shaped titanium alloy, available in 5
 sizes from 8mm to 16mm. It is indicated for use in patients with
 radiographically confirmed moderate to severe stenosis with neural element
 compromise resulting in claudication and/or radicular symptoms isolated to
 1 or 2 levels, in the region of L1 to L5.
     "This is a significant milestone for Paradigm Spine," said Marc R.
 Viscogliosi, Chairman and Chief Executive Officer of Paradigm. "It is the
 culmination of years of work developing intellectual property and
 conducting extensive scientific research into the effectiveness of our
 device."
     Gary L. Lowery, MD, PhD, Executive Vice President of Research and
 Technology for Paradigm, said, "I am excited to begin the US trial of the
 coflex(TM) device. More than 15,000 patients have been implanted with this
 device outside of the US over the last 11 years, and our extensive
 retrospective analysis of this population shows outstanding results.
 Patients have achieved significant relief of their symptoms, including
 lower back pain, and have overwhelmingly indicated they would have the
 surgery again. We anticipate similar results in our US trial."
     About Paradigm Spine, LLC
     The company's founding philosophy is "Surgeon Centric, Indication
 Specific, Data Driven", and focuses on providing the best clinical outcomes
 for patients suffering from chronic back pain. The company is concentrating
 on building a multi-product non-fusion portfolio. One product is the
 coflex(TM) device, a posterior non-fusion interspinous
 dynamically-functional implant, which has a long clinical history of over a
 decade of use and has been implanted in more than 15,000 patients suffering
 from low back pain and lumbar spinal stenosis.
     Paradigm Spine's second core platform is the Orthobiom(TM) technology,
 also in development for over a decade. The Orthobiom(TM) technology treats
 adolescent idiopathic scoliosis, a condition in children which causes
 severe curvature of the spine and which is usually surgically treated with
 a spinal fusion procedure. The Orthobiom(TM) system is a non-fusion
 alternative designed to preserve the motion and growth of the child's
 spine. It is a revolutionary product that could potentially help the lives
 of tens of thousands of children each year.
     For more, visit: http://www.paradigmspine.com
 
     Contact: Marc R. Viscogliosi
              Paradigm Spine, LLC
              (212) 583-9700 ext. 103
              marc.viscogliosi@paradigmspine.com
 
 

SOURCE Paradigm Spine, LLC

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