This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Barricaid® Anular Closure Device (ACD)
PMA Applicant: Intrinsic Therapeutics, Inc.
Address: 30 Commerce Way, Woburn, MA 01801, USA
Approval Date: February 8, 2019
Approval Letter: Approval Order
What is it? The Barricaid® Anular Closure Device (ACD), also referred to as “Barricaid," is an implant (device) inserted in the spinal bone (vertebrae) of the lower back to try to prevent another herniated discs (reherniation). The Barricaid is made of titanium and is attached to a polyester (polyethylene terephthalate or commonly referred to as PET) flexible woven polymer fabric mesh. The Barricaid is intended to close the hole in a patient's spinal bone (vertebrae) following a limited discectomy procedure in the lower back (L4-S1) after an initial herniated disc.
How does it work? The Barricaid rests in the edge of the cartilage in your spine (disc space) to reduce the number of potential reherniations.
When is it used? The Barricaid is indicated for patients with a numbness or weakness that extends to the buttock or legs, with or without back pain, caused by a herniation that is pinching a nerve root in the spine at one level between L4 and S1 that requires a limited discectomy procedure. This pinched nerve needs to first also be confirmed by your doctor to be due to a herniation in posterior side of your lower back through history, physical examination and imaging studies. During a limited discectomy procedure, the ruptured portion of the disc that is irritating or inflaming the nerve root is removed, leaving a hole in the patient's disc. If it is determined during the surgery that the size of the hole is between 4- 6 mm tall and 6-12 mm wide, the surgeon can implant the Barricaid. If the hole is not large, then the likelihood for another herniation or operation is naturally lower, and the patient does not qualify for use of this device.
What will it accomplish? The Barricaid is intended to reduce the chance of reherniation at that specific spinal level (L4-S1) from occuring. After a 3-year follow-up in a clinical study, patients receiving the Barricaid device had fewer reherniations compared to patients who did not receive the device. The reduced occurrence of reherniations also resulted in fewer additional surgeries. The results of the clinical study also showed the device did not prevent the patients from experiencing the benefits of reduced leg and/or back pain following limited discectomy surgery when compared to patients who did not receive the device.
When should it not be used? The Barricaid should not be implanted in patients with:
- Active general infection or infection where the implant will be placed
- A history of previous surgery in the same place in the spine
- Allergies to any of the device's components which are made of titanium, plastic/polyester, platinum and iridium
- Problems with bone density (osteoporosis or osteopenia)
- Lumbar spinal stenosis, or spinal deformities such as an abnormal curvature or "slip" of your spine, or unusual anatomy or structure in your spine that may make the surgery or placement of the device difficult or impossible
- The height of a disc in the back that is less than 5mm
- Anular holes that are:
- Wider than 10mm,
- Narrower than 6mm,
- Shorter than 4mm, or
- Taller than 6mm
- Insulin-dependent diabetes
- Damage to the nerves in the hands, feet, and arms, (Peripheral neuropathy), a problem with the blood flow in the arteries (arterial insufficiency), or
- A Body Mass Index (BMI) greater than 40
Additional information (including warnings, precautions, and adverse events):