A Post Marketing Surveillance Study
A Post Marketing Surveillance Study
This study is a prospective, multi-center study to monitor the early safety and performance
 of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used
 as an adjunct to limited discectomy.
This study is planned to collect information on use of the Barricaid ACD with an anchor width
 of 6mm. Other iterations of the device are made with an 8mm wide anchor. The narrower anchor
 was designed to optimize surgeon visualization during implantation, and has undergone all
 appropriate rigorous testing prior to release. Safety will be evaluated to demonstrate
 acceptable levels of device-related and procedure-related complications. This limited market
 release will allow its performance to be evaluated by examining the effects on reoperation,
 device deficiencies, patient pain scores and disability after discectomy with ACD.
Inclusion Criteria:

 -  Age 18 to 75 years old (male or female).

 -  Patients with posterior or posterolateral disc herniations at one level between L1 and
 S1 with radiographic confirmation of neural compression using CT and/or MRI.

 -  At least six (6) weeks of failed, conservative treatment prior to surgery, or requires
 immediate surgery to prevent permanent disability.

 -  Minimum posterior disc height of 5mm at the index level(s).

 -  Lower back pain and/or sciatica with or without spinal claudication.

 -  Oswestry Questionnaire score of at least 40/100 at baseline.

 -  VAS leg pain of at least 40/100 at baseline.

 -  Psychosocially, mentally and physically able to fully comply with the clinical
 protocol and willing to adhere to follow-up schedule and requirements.

 Exclusion Criteria:

 -  Spondylolisthesis Grade II or higher.

 -  Subject requires uni or bilateral facetectomy to treat leg/back pain.

 -  Subject has back or non-radicular leg pain of unknown etiology.

 -  Prior surgery at the index lumbar level.

 -  Subject requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less
 than -2.0 at the index level. For patients with a herniation at L5/S1, the average T
 score of L1-L4 shall be used.

 -  Subject has clinically compromised vertebral bodies at the index level(s) due to any
 traumatic, neoplastic, metabolic, or infectious pathology.

 -  Subject has sustained pathologic fractures of the vertebra or multiple fractures of
 the vertebra or hip.

 -  Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).

 -  Any metabolic disease bone disease that has not been stabilized for at least three
 months (e.g., Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or
 parathyroid gland disorder, etc.).

 -  Subject has an active infection either systemic or local.

 -  Subject has cauda equina syndrome or neurogenic bowel/bladder dysfunction.

 -  Subject has severe arterial insufficiency of the legs (Screening on physical
 examination= patients with diminution or absence of dorsalis pedis or posterior
 tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is
 required with vascular plethysmography. If the absolute arterial pressure is below
 50mm of Hg at the calf or ankle level, then the patient is to be excluded) or other
 peripheral vascular disease).

 -  Subject has significant peripheral neuropathy, patient defined as a patient with Type
 I or Type II diabetes or similar systemic metabolic condition causing decreased
 sensation in a stocking-like or non-radicular and non-dermatomal distribution in the
 lower extremities.

 -  Subject has insulin-dependent diabetes mellitus.

 -  Subject is morbidly obese (defined as a body mass index >40, or weighs more than 100
 lbs over ideal body weight).

 -  Subject has been diagnosed with active hepatitis, AIDS, or HIV.

 -  Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.

 -  Subject has a known allergy to titanium, polyethylene or polyester materials.

 -  Subject is pregnant or interested in becoming pregnant in the next two (2) years.

 -  Subject has active tuberculosis or has had tuberculosis in the past three (3) years.

 -  Subject has a history of active malignancy: A patient with a history of any invasive
 malignancy (except non-melanoma skin cancer), unless he/she has been treated with
 curative intent and there have been no signs or symptoms of the malignancy for at
 least two (2) years.

 -  Subject is immunologically suppressed, received steroids >1 month over the past year.

 -  Currently taking anticoagulants, other than aspirin, unless the patient can be taken
 off the anticoagulant for surgery.

 -  Subject has a current chemical/alcohol dependency or significant psychosocial
 disturbance.

 -  Subject has a life expectancy of less than three (3) years.

 -  Subject is currently involved in another investigational study.

 -  Subject is incarcerated.