A MULTI-CENTER, POST MARKETING SURVEILLANCE STUDYTO MONITOR THE SAFETY AND PERFORMANCEOF THE BARRICAID® ARD IN THE TREATMENT OF BACK ANDRADICULAR PAIN CAUSED BY PRIMARY LUMBAR DISCHERNIATION

Lumbar discectomy has become the most common spinal procedure in the US, with
nearly 300,000procedures performed each year because of the epidemic problem of
low-back pain, which leads to15 million physician visits per year and has
created a tremendous financial burden on societyexceeding $50 billion
annually.1,2,3,4 Low-back pain causes nearly 80% of injured workers to miss
atleast 8 weeks of work following a back injury.5 In persons younger than 45
years old, low-back pain isthe most frequent cause of activity limitation.6
Although only 4% of patients with low-back pain havean acute disc
herniation4,7, a disproportionate 30% of US annual costs for the treatment of
low-backpain are spent on this relatively small percentage of patients.8The
incidence of lumbar disc herniation peaks in patients between 24 and 45 years
of age with theincidence leading to surgery occurring most often in patients in
the 30- to 39-year-old range. 9 A malepredominance in the incidence of lumbar
disc surgery ranges from 1.3:1 to 2:1 because discs in menundergo higher
mechanical stress as well as inadequate nutrition due to longer nutrient
diffusionpathways.10,11 Other risk factors for herniated lumbar discs include
smoking, presence of narrowerlumbar vertebral canal, sedentary occupations,
prolonged motor vehicle driving, and operatingvibrating machinery.12,13 Most
surgeons initially manage patients with low-back pain and radicularsymptoms
with a trial of analgesic medications and physical therapy for several weeks
before

Safety and performance will be based on a comparison of overall success rates
of the Barricaid ARDand either a concurrent group (nonrandomized) of control
patients treated by conventional surgicalmethods (e.g., noninstrumented
discectomy) at select European sites or the published clinicalliterature on the
same patient population. Overall clinical success is based on a 15% improvement
inOswestry and a two point (2 point on a 10 point scale) improvement in VAS Leg
(combined) scores.Overall radiographic success requires maintenance of average
disc height (75% or greater ofpreoperative disc height). Safety will be judged
clinically using standard neurological assessmentsand clinically symptomatic
reherniation. A successful patient will not experience a loss ofneurological
function (at the index level) nor experiences reherniation at the original
defect site. Allreoperations that involve the removal/ repositioning of the
Barricaid ARD or the addition ofsupplemental hardware at the index level will
cause the patient to be classified as a failure. Inaddition, safety will be
documented based on the type and rate of occurrence of adverse eventsoccurring
during the study. The Barricaid ARD will be determined to be safe and
performing asintended if the Barricaid ARD rates of overall success are
equivalent or better than the controlpopulation.

This clinical trial is a prospective, multicentre, historical controled study
to evaluate the safety and performance of the Barricaid ARD by treatment of
lumbal disc herniation

NVT

The risks of the BARRICAID* surgery combined with the conventional treatment
are: a) infection of wounddrainage; b)return of the herniation; c)effects on
the central nerve system;d) same symptoms as before the surgery; e) migration
of the device in of out the lumbal disc;f)death  as complication of the surgery
or anesthesia