Prestige
Cervical Disc
Prestige Cervical Disc image

Prestige Cervical Disc

The Prestige® Cervical Disc, designed to maintain motion in the neck, offers surgeons and their patients an alternative to spinal fusion.

How It Works

The Prestige® Cervical Disc offers surgeons treating patients with radiculopathy and myelopathy related to cervical disc degeneration an alternative to spinal fusion surgery. Constructed of stainless steel in a unique, two-piece ball-and-trough configuration, the device is designed to maintain motion at the treated vertebral segment.

The Prestige Cervical Disc treats a diseased or damaged disc and is designed to maintain motion. Made of stainless steel, the device has two articulating components (a ball on top and a trough on the bottom) that are inserted into the disc space and attached to the vertebral bodies on either side. The Prestige Cervical Disc was designed to allow for the following motions: flexion/extension and anterior/posterior (AP) translation, lateral bending, and unconstrained axial rotation.

The Prestige Cervical Disc is available in a variety of sizes to accommodate patient anatomy. While many factors contribute to the longevity of a cervical artificial disc, the Prestige disc has undergone significant testing to verify the safety and adequate durability of the device.

Benefits

The Prestige Cervical Disc as an alternative to spinal fusion was evaluated in a clinical study that involved 541 patients – the largest clinical study of its kind ever conducted and completed for the cervical spine. Some key findings of the clinical study include:

  • The group of patients receiving the Prestige Cervical Disc had a median return to work that was 26.2% earlier than the median in the spinal fusion treatment group.
  • Patients in the Prestige Cervical Disc group experienced no device failures (breakages).
  • Fewer patients in the Prestige Cervical Disc group required revision surgical procedures than those in the spinal fusion treatment group at 24 months. A revision surgery was defined as a procedure that adjusts or in any way modifies the original implant configuration.

Risks

Along with the benefits of this technology, there also are potential risks. Risks associated with the Prestige Cervical Disc include, but are not limited to:

  • Early or late loosening of the components
  • Component sizing issues
  • Anatomical or technical difficulties
  • Possible tissue reaction
  • Formation of bone that may reduce spinal motion or result in a fusion, either at the treated level or adjacent levels
  • The development of new radiculopathy, myelopathy, or pain

In the US clinical study, there were a number of adverse events. Some of the most common were trauma, difficulty swallowing, impairment of speech, and infection. There may be other risks associated with treatment using the Prestige device. Although many of the major risks are listed on this website, a more comprehensive list is provided in the physician’s package insert for the product and the Indications, Safety, and Warnings link.

Medtronic cervical artificial discs should only be used by surgeons who are experienced in the surgical procedure and who have received adequate training with the device. A lack of adequate experience and/or training may result in a higher incidence of adverse events, which may require additional surgery for correction.  

Specifications

The Prestige® Cervical Disc is a two-piece, articulating, metal-on-metal device that is inserted into the intervertebral disc space at a single cervical level using an anterior approach. The device is manufactured from wrought type 316 stainless steel (ASTM F-138) and consists of two metal plates that function via a ball-and-trough mechanism. The superior component of the implant contains the ball portion of the mechanism, and the inferior component incorporates the trough portion. The flat portion of each component, which contacts the vertebral end plate, is roughened through a grit blasting process.

Each component is affixed to the vertebral body by two bone screws through an anterior flange. The bone screws are held in place by a lock screw mechanism. In the implanted disc, the bone screws are divergent in the cephalic/caudal direction and convergent in the medial/lateral direction.

The device assembly was designed to allow the following motions ex vivo: a minimum of 10° motion off the neutral position in flexion/extension and lateral bending, unconstrained axial rotation, and 2 mm of anterior/posterior translation.

The Prestige Cervical Disc has been indicated by the U.S. Food and Drug Administration (FDA) in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The device is implanted through an open anterior approach. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (eg, pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (eg, CT, MRI, x-rays): 1) herniated disc, and/or 2) osteophyte formation.

Last updated: 22 Sep 2010

Medtronic Spinal and Biologics

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