Patient Selection

Overview

Artificial disc surgery with the Prestige^® Cervical Disc offers surgeons and their patients an alternative to spinal fusion. The Prestige Cervical Disc is designed to maintain motion at the treated vertebral level. The device is generally indicated for use in skeletally mature patients for disc reconstruction in the C3-C7 levels following a single-level cervical discectomy for the treatment of intractable radiculopathy and myelopathy, and is implanted via an open anterior approach.

Artificial disc surgery with the Prestige Cervical Disc may be an appropriate treatment option for patients who:

• Are experiencing neck pain
• Are experiencing pain radiating down the arms
• Are experiencing numbness or weakness in the hands and extremities
• Have exhausted nonsurgical therapies
• Require treatment only at one level of the neck
• Are at least 18 years of age with skeletal maturity
• Do not have an active infection
• Do not have an allergy to stainless steel

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

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.

For complete information regarding indications for use, warnings, precautions, adverse events, and methods of use, please reference the device’s package insert and instructions for use, and the Indications, Safety, and Warnings link.

The Prestige Cervical Disc 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.

Patient selection is extremely important. For complete information regarding indications for use, warnings, precautions, adverse events and methods of use, please reference the device’s package insert and instructions for use.

Patient Assessment

The Prestige^® Cervical Disc is indicated for use in skeletally mature patients for disc reconstruction at the C3-C7 levels following a single-level cervical discectomy for the treatment of disc degeneration-related symptoms that have not improved with conservative care.

The ideal patient would have radiculopathy pain shooting into their arms or hands in a pattern which matched a disc problem at the correct level of the neck. Many would also have accompanying neck pain. Some patients would also have weakness in arm or hand muscles and numbness or tingling in their arms or hands.

Patients who have neurological symptoms and/or failed conservative therapy and fall in the criteria listed above would be candidates for surgical intervention.

Patients should have a documented history of intractable radiculopathy or myelopathy accompanied by radiographic evidence (CT, MRI, x-ray, etc.) of disc degeneration (disc herniation and/or osteophyte formation) at the C3-C7 levels.

Patient selection is extremely important. For complete information regarding indications for use, warnings, precautions, adverse events and methods of use, please reference the device’s package insert and instructions for use.

Selection Criteria

The Prestige^® Cervical Disc is generally indicated for use in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy. The device is implanted via an open anterior approach.

Intractable radiculopathy 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): herniated disc and/or osteophyte formation.

Cervical artificial disc replacement surgery with a Prestige Cervical Disc may be appropriate for patients who:

• Are experiencing neck pain
• Are experiencing pain radiating down the arms
• Are experiencing numbness or weakness in the hands and extremities
• Have exhausted nonsurgical therapies
• Require treatment only at one level of the neck
• Are at least 18 years of age with skeletal maturity
• Do not have an active infection
• Do not have an allergy to stainless steel

The Prestige Cervical Disc should not be implanted in patients with an active infection or with an allergy to stainless steel.

Precautions include, but are not limited to:

• More than one cervical level with degenerative disc disease (DDD)
• Not skeletally mature
• Clinically significant cervical instability
• Prior fusion at adjacent cervical level
• Severe facet joint pathology of involved vertebral bodies
• Prior surgery at treated level
• Osteopenia, osteomalacia, or osteoporosis as defined by bone mineral density T-score of 3.5, or 2.5 with vertebral crush fracture
• Spinal metastases
• Chronic or acute renal failure or history of renal disease
• Taking medications known to potentially interfere with bone/soft tissue healing (eg, steroids)
• Pregnancy
• Severe, insulin-dependent diabetes

In addition, safety and effectiveness of the device has not been established in patients who have not undergone at least six weeks of conservative treatment or had signs of progression or spinal cord/nerve root compression with continued nonoperative care.

Implanted metal alloys release metallic ions into the body (especially those devices with metal-on-metal articulating surfaces). The long term effect of these ions on the body is not known.

Patient selection is extremely important. For complete information regarding indications for use, warnings, precautions, adverse events and methods of use, please reference the device’s package insert and instructions for use.