The oval spacer fits between the spinous processes and the wings are designed to prevent the implant from moving.
Warning: The X-STOP® Implant is manufactured from a titanium alloy of metal. Please inform your doctor if you think you are allergic to titanium or titanium alloy.
Caution: The X-STOP® Impant is manufactured from a titanium alloy which is known to produce artifacts if you undergo an MRI exam.
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The DIAM™ System is a product that can be used to treat spinal conditions that cause low back pain and radiating leg pain.
Through a small incision, the DIAM™ System implant is inserted between two spinous processes to treat spinal stenosis. The spinous process is the portion of the vertebrae that protrudes from the back of the spinal column. They create the "bumps" that you can feel along the middle of your back.
The core of the DIAM™ System implant is made of silicone. The outer mesh and tether are made of medical-grade polyester. The crimp is titanium. The device is available in a variety of sizes to allow the surgeon to accommodate the patient's individual anatomy.
Although a lumbar spinal fusion is currently a very good option for many patients, the DIAM™ System clinical trial will study this treatment option for patients suffering from spinal stenosis.
History of the DIAM™ Spinal Stabilization System
Fourteen different published European studies with 527 patients
More than 27,000 current DIAM™ System patients from outside the United States
How Can I Enroll?
To participate in the clinical trial, you must meet the following criteria:
Have lumbar spinal stenosis at single level between L2 – L5
Be at least 35 years of age, inclusive
Be able to sit for 30 minutes without severe pain
Be able to walk at least 100 feet without assistance
Not be pregnant or planning a pregnancy during the study
At least six months of non-operative treatment prior to enrollment
All potential candidates are subject to the above and additional non-listed clinical trial criteria.
The DIAM Spinal Stabilisation System can be used with minimally invasive surgical techniques, and provides flexible support of the lumbar spine while treating spinal degeneration. The "Device for Intervertebral Assisted Motion" (DIAM) is a new technology from Medtronic that treats back problems without the need for spinal fusion.
The DIAM Spinal stabilisation system was designed to aid in the treatment of degenerative disc disease. The DIAM acts as a spacer which when placed between two spinous process restores the natural height of the disc, taking the pressure off the intervertebral disc and associated structures, and allows the nerve to exit freely from the spinal cord while maintaining normal movement of the spine. The device is made of a hardened silicone covered with a polyethylene sock and has two ligatures, which allow it to be secured in place between the two spinous processes.
What are the advantages of the DIAM system?
Following standard surgery where a part of the intervertebral disc is removed (discectomy), the rest of the disc can degenerate further potentially requiring fusion surgery at a later date. In fusion surgery the surgeon uses a bone graft to join, or fuse, two or more vertebrae together. Once the bone and spinal bone grow together, the two vertebrae function as one unit, stabilizing that part of the spine. With the disc space restored to its original height, pressure on nerves is usually relieved. The DIAM spinal stabilization system negates the need for fusion in some patients and can act as an alternative for fusion in some patients. The device is designed to assist in allowing normal motion in the spine. In addition, the device may help to protect the spine from mechanical stress that can cause further degeneration of discs near the level of surgery.
Who can benefit from surgery?
You may benefit from the DIAM spinal stabilization system if:
has confirmed by your history and xray studies that you have degenerative disc disease in your lower back;
You have narrowing of a vertebral opening due to loss of disc height; or
You have back and/or leg pain that has not responded to non-surgical treatment.
How is the surgery performed?
The DIAM spinal stabilisation system surgery takes only a short time added onto the standard procedure of discectomy. The surgeon will access your spine through an opening in your back, remove portions of the degenerated disc, measure the required height and then position the DIAM to maintain function of your spine. There are alternative treatments to this surgery, both surgical and non-surgical. You should discuss these options with the surgeon before making your decision.
What is the recovery process?
Immediately after surgery, you will be moved to the recovery room where you will remain for a few hours while your recovery from the anaesthesia is monitored. After you awaken fully, you will be taken to your hospital room. You may have a drainage tube in your wound and the surgeon may prescribe medicines to control pain and nausea. Ask the surgeon about your hospital stay and your specific recovery plan following surgery. It is important to follow your doctor's instructions carefully to recover from surgery as quickly as possible and increase your chances of a successful outcome. After surgery the surgeon may refer you to a physical therapist that will teach you exercises to improve your strength and mobility. The goal of physical therapy is to help you become active as soon as possible, using safe body movements that protect your back. You and your surgeon will continue to work together during your recovery. Before you leave the hospital, the surgeon may schedule follow up visits with you so he can evaluate your progress.
What are the possible complications?
As with any surgery, spinal surgery is not without risk. Complications, such as infection, blood loss, bowel or bladder problems, are some of the potential adverse risks. Please consult the surgeon for a complete list of indications, warnings, precautions, adverse events, clinical results and other important medical information, if necessary.
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Approach
• Posterior
Levels
• L1-L5
Indications
The Wallis mechanical normalisation system treats low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification)* in the following indications :
• Massive herniated disc in young adults / Recurrent herniated disc / Herniated disc accompanying an L5 sacralization transitional anomaly
• Degenerative disc disease at a segment adjacent to fusion
• Degenerative lesions with or without Modic 1
• Lumbar canal stenosis treated by laminotomy (not by complete laminectomy)**
Contraindications
• Grade V degenerative lesions in the MRI classification of Pfirrmann
• Spondylolisthesis
• Osteoporosis
• Nonspecific low back pain
• Modic 2 and Modic 3
Christie, S. D., J. K. Song, et al. (2005). "Dynamic interspinous process technology." Spine 30(16 Suppl): S73-8.
STUDY DESIGN: A literature review. OBJECTIVES: To evaluate the mechanisms of action and effectiveness of interspinous distraction devices in managing symptomatic lumbar spinal pathology. SUMMARY OF BACKGROUND DATA: Fusion operations have traditionally been used to manage many disorders of the lumbar spine related to deformity, pain, or instability. Concern over the long-term effects of fusion on adjacent segments has led to the development of the concept of dynamic stabilization. METHODS: A Medline search was performed using the key words "interspinous implants," "interspinous devices," and "lumbar dynamic stabilization." The abstracts of each were reviewed. Relevant articles were reviewed in detail and other appropriate references obtained. In addition, when available, nonpublished manufacturer's information was reviewed. RESULTS: Articles describing the following implants were included in this review: the Minns Device, the Interspinous "U," the Diam, the Wallis Implant, and the X STOP. CONCLUSIONS: These devices continue to be evaluated in clinical trials. Early results suggest a possible role in the management of degenerative disorders of the lumbar spine.
Floman, Y., M. A. Millgram, et al. (2007). "Failure of the Wallis interspinous implant to lower the incidence of recurrent lumbar disc herniations in patients undergoing primary disc excision." J Spinal Disord Tech 20(5): 337-41.
BACKGROUND: Ipsilateral recurrent disc herniation after lumbar discectomy is a significant problem in the management of lumbar disc disease and may necessitate repeat surgical intervention. A population-based study in Finland found that about 14% of all primary lumbar discectomies required additional surgical interventions. Interspinous devices, which have been shown to unload the posterior anulus, may reduce the occurrence of recurrent herniations. We report our short-term experience with the use of the Wallis device in the management of patients with lumbar disc herniation undergoing primary disc excision. PATIENTS AND METHODS: Thirty-seven consecutive patients (23 males and 14 females, average age 36 y) underwent primary lumbar disc excision followed by fixation of the segment with the Wallis implant during a period of 1 year. Indications for implanting the Wallis device were a voluminous disc herniation and preservation of at least 50% of disc space height. Surgery was performed at level L4-5 in most patients. Average follow-up after surgery was 16 months (range 12 to 24). The last 14 patients were also evaluated by the preoperative and postoperative Oswestry Disability Index (ODI) questionnaire, the SF-36 survey, and by a visual analog scale (VAS) for back and leg pain. RESULTS: The average ODI dropped from 43 to 12.7. The average VAS for back pain dropped from 6.6 to1.4 and the average Vas for leg pain dropped from 8.2 to 1.5. Five patients (4 males and 1 female) with relapsing leg pain were diagnosed by contrast-enhanced magnetic resonance imaging as suffering from recurrent herniation (5/37, 13%). All reherniations occurred at level L4-5 level between 1 and 9 months after the index surgery. Two of the 5 patients subsequently underwent additional discectomy and fusion. SUMMARY: The current Wallis implant is probably incapable of reducing the incidence of recurrent herniations, but it still may be useful in patients with discogenic back pain due to early degenerative disc disease.
Senegas, J., J. M. Vital, et al. (2007). "Long-term actuarial survivorship analysis of an interspinous stabilization system." Eur Spine J 16(8): 1279-87.
In 1986, an interspinous dynamic stabilization system (the prototype of the current Wallis implant) was designed to stiffen unstable operated degenerate lumbar segments with a hard interspinous blocker to limit extension and a tension band around the spinous processes to secure the implant and limit flexion. Restoring physiological mechanical conditions to the treated level(s) while preserving some intervertebral mobility was intended to treat low-back pain related to degenerative instability without increasing stress forces in the adjacent segments. The procedure was easily reversible. If low back pain persisted or recurred, the device was removed and stability was achieved using fusion. The intermediate-term results were promising, but the long-term safety and efficacy of this dynamic interspinous stabilization device has not been previously documented. We retrospectively reviewed the hospital files of all the patients (n = 241) who had this dynamic stabilization system implanted between 1987 and 1995, contacting as many as possible to determine the actuarial survivorship of the system. In this manner, 142 of the 241 patients (58.9%) were contacted by telephone. The endpoints used for the survivorship analysis were 'any subsequent lumbar operation' and 'implant removal'. At 14 years follow-up, values of actuarial survivorship with 95% confidence interval were 75.9 +/- 8.3 and 81.3 +/- 6.8% for the endpoints 'any subsequent lumbar operation' and 'implant removal', respectively. There was no difference in survivorship of multiple-level implants with respect to single-level devices. Although the conclusions of the present study must be tempered by the 41% attrition rate, these findings support the long-term safety of this system, and possibly long-term protective action against adjacent-level degeneration by motion preservation. Outcomes at least equivalent to those of fusion were observed without the primary drawbacks of fusion.
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