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: Prestige LP Cervical Disc
PMA Applicant: Medtronic Sofamor Danek USA, Inc.
Address: 1800 Pyramid Place Memphis, TN 38132
Approval Date: July 24, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090029a.pdf
What is it? The Prestige LP Cervical Disc treats one diseased disc in the neck (cervical disc) that causes arm pain and/or weakness or numbness (radiculopathy or myelopathy). The Prestige LP Cervical Disc consists of a titanium-ceramic alloy that fits between the top and bottom surface of the neck bones (cervical vertebrae).
How does it work? The implanted device is placed between two adjacent cervical vertebrae to replace a diseased cervical disc. It is designed to maintain the distance between two adjacent cervical vertebrae. The device also allows for a range of motion including bending and rotation.
When is it used? The Prestige LP Cervical Disc is intended for people who have stopped growing (skeletally mature patients) to replace a cervical disc (from C3-C7) following the removal of a diseased or bulging disc.
What will it accomplish? The device should help maintain the disc space so that it doesn’t collapse. Unlike a fusion procedure, the Prestige LP Cervical Disc is designed to allow a range of motion including bending and rotation. In a study that compared the Prestige LP Cervical Disc to cervical fusion, the overall success rate of the investigational group was 215 out of 271 subjects (79.3%) compared to 147 out of 220 subjects (66.8%) for the control group at 24 months.
The effects of the diseased disc removal should include pain relief and improved function. The rate of severe and device-related adverse events was comparable between the Prestige LP and the control group. Some of the most common adverse events experienced by study patients were neck and/or arm pain, numbness, back and/or leg pain, and difficulty swallowing.
When should it not be used? You should avoid having surgery with the Prestige LP Cervical Disc if you are experiencing any of the following conditions:
- Active whole body (systemic) infection, such as sepsis.
- An infection at the surgical site such as a skin rash or an infected cut.
- Low bone mineral density such as osteoporosis or osteopenia (defined as a DEXA bone mineral density T-score less than or equal to -1.0).
- A known allergy or sensitivity to the materials in the device (titanium, aluminum or vanadium).
- A cervical spine that shows an unhealthy amount of extra movement (instability). This can be measured by X-rays taken on the patient’s side when the spine is still and bent.
- Severe degeneration of the cervical spine (spondylosis) at the level to be treated, characterized by bridging bone between two vertebrae, loss of disc height, or an absence of motion as this may lead to a limited range of motion and may encourage bone formation (such as heterotopic ossification and fusion).
- Severe disease or degeneration in the joints on the back of the cervical vertebrae (facet joints).
- Damaged cervical vertebrae from an accident (trauma) at the affected level of the neck (such as nonunion).
- An abnormal shape (deformity) of the cervical vertebrae at the affected level of the neck. Deformity could be caused by an inflammatory disease (such as ankylosing spondylitis or rheumatoid arthritis).
- Symptoms caused by more than one cervical level.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.