FDA Approves 'IDE' Clinical Trial Of Paradigm Spine's Coflex(TM) Functionally Dynamic Interspinous Implant

Main Category: Neurology / Neuroscience
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 11 May 2006 - 0:00 PDT


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

Paradigm Spine, LLC
http://www.paradigmspine.com

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