Category: MIS Lateral Lumbar Interbody Fusion (LLIF)
The VIPER® 2 System is a single platform solution with a comprehensive range of instrumentation and implant options. The VIPER 2 System provides surgeons with the confidence and control required to address a wide range of spinal pathologies, including the more advanced indications while maintaining a less invasive approach. The VIPER 2 System makes degenerative MIS cases easier and complex MIS cases possible with a single versatile system.
The system features more than 30 comprehensive instruments designed to handle multiple pathologies, from degenerative to deformity. The VIPER 2 System offers many benefits to the surgeon including a streamlined surgical approach with ease of use, simple reduction options and versatile rod insertion as well as a potential benefit to the patient (minimal muscle trauma).
Why MIS? Minimally invasive approaches have been shown to typically reduce complications, overall costs, pain, infection rates, and blood loss and yield quicker recovery than traditional open surgery.
The VIPER Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The VIPER Spine System is intended for non-cervical pedicle fixation and non-pedicle fixation for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumour; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System are intended for non-cervical pedicle fixation and non-pedicle fixation for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumour; pseudarthrosis; and failed previous fusion in skeletally mature patients.
Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.
Active systemic infection or infection localised to the site of the proposed implantation are contraindications to implantation.
Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.
Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.
WARNINGS, PRECAUTIONS, AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES
Following are specific warnings, precautions, and possible adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.
A. The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the appliance and the operation.
B. The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain, twisting, repetitive bending, stooping, running, substantial walking, or manual labour, he/she should not return to these activities until the bone is fully healed. Even with full healing, the patient may not be able to return to these activities successfully.
C. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.
D. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary remedy.
E. Foreign body sensitivity. The surgeon is advised that no preoperative test can completely exclude the possibility of sensitivity or allergic reaction. Patients can develop sensitivity or allergy after implants have been in the body for a period of time.
F. Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. Additionally, smoking has been shown to cause diffuse degeneration of intervertebral discs. Progressive degeneration of adjacent segments caused by smoking can lead to late clinical failure (recurring pain) even after successful fusion and initial clinical improvement.
SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted metal implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage. Reuse can compromise device performance and patient safety. Reuse of single use devices can also cause cross-contamination leading to patient infection.
CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of metal implants should only be done with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease the fatigue life and may cause failure.
CONSIDERATIONS FOR REMOVAL OF THE IMPLANT AFTER HEALING. If the device is not removed after the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery.
ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant, and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sports participation. The patient should understand that a metallic implant is not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may migrate and damage the nerves or blood vessels. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.
CORRECT PLACEMENT OF ANTERIOR SPINAL IMPLANT. Due to the proximity of vascular and neurologic structures to the implantation site, there are risks of serious or fatal haemorrhage and risks of neurologic damage with the use of this product. Serious or fatal haemorrhage may occur if the great vessels are eroded or punctured during implantation or are subsequently damaged due to breakage of implants, migration of implants or if pulsatile erosion of the vessels occurs because of close apposition of the implants.
|MINIMAL-INVASIVE WIRBELSÄULEN-OP VERSTEHEN||Understanding Minimally Invasive Spinal Surgery|
|Understanding Minimally Invasive Spinal Surgery - ES||Understanding Minimally Invasive Spinal Surgery - FR|
|Understanding Minimally Invasive Spinal Surgery - IT||Viper 2 Minimally Invasive Pedicle Screw / Viper System|
Two-step extension loading
Low-profile extensions and rod holders
|Secure rod and screw extensions||