From the Disc. For the Disc.

Determining Discogenic Low Back Pain

Discogenic low back pain can be determined through a combination of symptoms, physical examination and imaging. Pain typically manifests itself as medial back pain with or without radicular leg pain. The pain is exacerbated most when leaning forward as this weight-bearing position puts the most pressure on the painful disc.

Nucleus pulposus (NP) is the inner core of the vertebral disc composed of a jelly-like material that primarily consists of water and a loose network of collagen fibers. This elastic inner structure allows the vertebral disc to withstand forces of compression and torsion. Age and injury can cause this inner core to become dehydrated.

What is VIA Disc NP?

VIA Disc NP is intended for use as an allograft to supplement nucleus pulposus tissue loss in degenerated intervertebral discs. An allograft is tissue recovered from a human donor that is transferred to a human recipient.

VIA Disc NP consists of dehydrated nucleus pulposus particulate derived from the intervertebral disc region of the donor.

The nucleus pulposus particulate is mixed together with saline and delivered into the intervertebral disc during a non-surgical spinal procedure.

VIA Disc NP Key Features

Off-the-shelf allogeneic graft.

Disc NP is a minimally invasive procedure that can be delivered through a 20G spine needle.

Consistent mixing in fully closed container to reduce contamination risk.

In-vitro testing of nucleus pulposus tissue demonstrates ability of disc to absorb water similar to original nucleus pulposus tissue. Transplanted nucleus pulposus tissue may support biomechanical function of the supplemented disc.

VIA Disc NP is the first and only …

nucleus pulposus (NP) allograft intended to support the cushioning function of the intervertebral disc (IVD) and supplement a patient’s tissue loss due to intervertebral
disc degeneration.

How VIA Disc NP Works

What to Expect with VIA Disc NP?

The nucleus pulposus particulate is mixed together with saline for delivery into your intervertebral disc. Intravenous (IV) antibiotics may be given before the VIA Disc NP procedure to reduce risk of infection.

The VIA Disc NP procedure is performed under strict sterile conditions. The VIA Disc NP procedure can be performed under local anesthesia or moderate sedation may be recommended by your physician. A procedure involving your pain generating intervertebral disc can be painful. During the procedure, your physician will use fluoroscopy (a computer tomography scan that continues to take images during the procedure so that the physician can see where the needle is going). Your physician will insert a needle through the skin and muscle into the center of the intervertebral disc. VIA Disc NP will slowly be delivered into the center of the intervertebral disc.

You may experience pain and soreness after the procedure, which is normal. This pain may be due to increased pressure within your intervertebral disc. It is important to follow your physician’s instructions after the procedure. You may be instructed to keep your activity to the normal activities of daily life and limit physical or strenuous activity for 72 hours post-procedure. Your physician may prescribe certain pain medications (e.g. analgesics, steroid dose pack, muscle relaxants). You may experience moderate to severe pain after an injection into an intervertebral disc, and oral medications may be needed promptly to treat this post injection pain and discomfort. An ice pack may be given to place over the injection site in the event of post-injection site discomfort. Your physician may suggest a back brace or recommend physical therapy to make you feel more comfortable following your procedure. A follow-up appointment will typically be scheduled two to four weeks after the procedure to monitor your pain and comfort. Additional follow-up appointments may be scheduled at the discretion of your physician to assess your condition. It is important that you consult with your physician for medical advice, including any questions you may have regarding the VIA Disc NP product or the associated procedure.

Risks with Allograft Products like VIA Disc NP and the Associated Procedure
Careful donor screening, laboratory testing, and tissue processing, including sterilization via electron-beam irradiation of the disc tissue, have been used to minimize the risk of transmission of applicable diseases to the patient. Tissue donors are thoroughly screened and tested to meet or exceed safety standards mandated by the FDA and AATB. VIA DISC NP may be exposed to Gentamicin or Vancomycin, trace amounts may remain. As with any processed human donor tissue, VIA Disc NP cannot be guaranteed to be free of all pathogens. ADVERSE EVENTS: Possible adverse events may include: Transmission of disease of unknown cause and transmission of infectious agents including but not limited to: HIV, hepatitis, syphilis, or microbial contaminants, pain and/or inflammation/swelling near the injection area in your spine or back, hematoma – a collection of blood at the site of the injection, epidural bleedings – a collection of blood in the potential space between the dura (covering of the spinal cord) and the bone, along the spinal canal (hollow passage through the back bones through which the spinal cord runs), infections (for example, at the injection site, in the spinal disc or bone in your spine and/or meningitis), neurological deterioration, such as loss of feeling or tingling or weakness, as serious as paralysis of the legs or lower body, sexual dysfunction, cerebrospinal fluid fistula (CSF), a spinal fluid leak, relapsing herniation, herniated disc material at the same level as the procedure, bladder (urination) or bowel dysfunction, vertebral end plate inflammation, or damage to endplates can occur with disc and/or endplate degeneration.

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