DIAM MEDTRONIC PDF

Inclusion Criteria: Each patient participating in this clinical trial must meet all of the following inclusion criteria: Has moderate low back pain secondary to lumbar degenerative disc disease at a single level from L2 - L5. Low back pain is defined as persistent back pain, with or without radicular pain, with current episode of less than one year duration. Is years of age, inclusive, and is skeletally mature. Has been treated nonoperatively e.

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Interspinous Spacer How long a recovery period can I expect after surgery? Following your discharge from the hospital, physiotherapy may be recommended. Your doctor may schedule a follow-up exam approximately six weeks later. While your doctor may impose limitations on your physical activities in the weeks following your operation, you may be able to travel and engage in light activity as soon as you feel able.

In some cases, normal activity may be resumed with weeks after the procedure, provided your doctor has given you permission to do so. If you are planning to have other diagnostic procedures or treatments, you should inform all doctors involved in your care that you have had spinal surgery.

Failure to follow postoperative care recommendations may result in recurrence of symptoms and discomfort. A stress fracture of the spinous process may occur if strenuous physical activity is resumed too soon postoperatively. An assessment of surgery for spinal stenosis: time trends, geographic variations, complications, and reoperations. Information on this site should not be used as a substitute for talking with your doctor.

Always talk with your doctor about diagnosis and treatment information. Related Links.

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DIAM (Device for Intervertebral Assisted Motion) Spinal Stabilization System

Interspinous Spacer How long a recovery period can I expect after surgery? Following your discharge from the hospital, physiotherapy may be recommended. Your doctor may schedule a follow-up exam approximately six weeks later. While your doctor may impose limitations on your physical activities in the weeks following your operation, you may be able to travel and engage in light activity as soon as you feel able.

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Company News Feature

The device, according to Medtronic, differs from other interspinous process spacers in its implant material, proposed indications and clinical trial study design. Medtronic is the second biggest medical device company on the planet with the biggest slice of the spine market. Gaining FDA approval is something economists call "economic rent. As the second largest medical device company in the world, one would expect Medtronic to be masters of this universe. With small competitors like VertiFlex, Inc. So what happens now? Will the company shelve the system?

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Interspinous Process Spacers

The first is implanted beside and under the spinous process. The second piece is plate-like and is placed on the opposite side of the spinous process and is then attached to the first. In the study evaluating the device, the primary indications were age of at least 50 years, lower extremity pain with or without back pain secondary to a confirmed diagnosis of lumbar spinal stenosis that was relieved with flexion forward bending , and able to walk at least 50 feet. Patients were not enrolled in the study if they had a fixed motor deficit or more than mild grade spondylolisthesis. Results of the multi-center trial conducted in the US indicated that among patients with pain arising from neurogenic claudication a symptom of spinal stenosis , the X-STOP provided significantly greater pain relief than epidural steroid injections the treatment used as a comparative control. A clinical trial, conducted outside the United States, was initiated in , involving patients who were all treated for recurrent disc herniation.

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