Description
The Vista-S Device is manufactured wholly from unfilled PEEK-OPTIMA LT1, a polyetheretherketone. This material is a thermoplastic polycondensate, semicrystalline polymer. It is used in this device in the unfilled state (i.e., no glass or carbon fiber fill). Due to the radiolucent nature of PEEK-OPTIMA LT1, three radiopaque markers made of tantalum are incorporated into the device to indicate the nose end and the superior and inferior corners of the opposite end for use in postoperative monitoring of device position.
The superior and inferior surfaces of the device have a textured surface to provide increased stability. The device is available in a variety of cross-sectional geometries and sizes. These implants offer two different included angle options to maintain the natural contour of the spine. These implants are intended for single use only and must not be reused under any circumstances. Surgical instruments are also available to assist in the implantation of the device.
Indications
The Vista-S Device is intended for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with symptomatic cervical disc disease from the C3-C4 to the C7-T1 disc. The Vista-S Device is intended for use with supplemental internal spinal fixation systems. The Vista-S Device may be used with bone graft.
Contraindications
- Active local infection in or near the operative region.
- Active systemic infection and/or disease.
- Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation.
- Prior surgical procedure using the desired operative approach.
- Spinal conditions other than cervical DDD.
- Current metastatic tumors of the vertebrae adjacent to the implant.
- Known or suspected sensitivity to the implant materials.
- Endocrine or metabolic disorders known to affect osteogenesis (e.g., Paget disease, renal osteodystrophy, hypothyroidism).
- Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs.
- Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g., current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury).
- Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure or complications in postoperative care. Neuromuscular disorders include spina bifida, cerebral palsy and multiple sclerosis.
- Pregnancy.
- Patients unwilling to follow postoperative instructions, especially those in athletic and occupational activities.
- Morbid obesity.
- Symptomatic cardiac disease.
- Skeletal immaturity.
- Grossly distorted anatomy.
- Conditions other than those indicated.