The Biomet Spine® Spinous Process Fusion Plate (also known as Aspen® MIS Fusion System) is a spinous process fixation device intended to provide temporary fixation of spinal segments in the thoracic, lumbar, and sacral spine while awaiting bony fusion to take place. As with all orthopedic surgical procedures, detailed preoperative planning is essential. Preoperative diagnostic evaluation followed by carefully executed surgical technique is required. Postoperative care, individualized to suit the particular injury/disease requirements, is essential for optimum outcome. The surgeon must be fully aware of the risks and complications inherent to this type of surgery. Only those individuals with specialized training and experience in spinal surgery should attempt use of the implants.
The Aspen system is a posterior attachment spinal fixation system composed of spinous process plates, dedicated surgical instruments, and sterilization cases. The components are used to build a construct to provide stabilization of spinal segments in the thoracic, lumbar and sacral spine to support fusion. The Aspen device is part of the Biomet Spine Spinal Fixation System, which offers the surgeon a variety of implant components from which to assemble a suitable construct according to each individual patient's needs and requirements. It is essential to use the Biomet Spine implants with their specifically designed instruments.
The Aspen implants are made of titanium alloy, Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3 standards. The Biomet Spine Spinal Fixation System also includes other implants made from commercially pure titanium per ASTM F67 and from cobalt chrome alloy per ASTM F1537. Titanium and cobalt chrome implant components may be used together within the same construct. Titanium and cobalt chrome implants should never be used with stainless steel implants.
Indications for Use
The Aspen system is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1- S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease(defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Aspen device is intended for use with bone graft material, not intended for stand-alone use.
Contraindications may be relative or absolute. The choice of a particular device must be carefully weighed against the patient's overall evaluation. Circumstances listed below may reduce the chance of a successful outcome. Contraindications include, but are not limited to:
Possible complications specific to the device may include:
Other general complications associated with any spinal surgical procedure may include: non-union or delayed union, pseudarthrosis; pain; second surgery; bleeding; infection, early and late; tissue or nerve damage, including dural tears or other neurological problems; incisional complications; scar formation; damage to blood vessels and cardiovascular system compromise; changes in mental status; damage to internal organs and connective tissue; complications due to the use of bone grafting, including graft donor site complications; respiratory problems; reactions to anesthesia and/or death.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery, where many extenuating circumstances may compromise the results