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
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
SOURCE Paradigm Spine, LLC