Medtronic Inc. announced that the U.S. Food and Drug Administration (FDA) have granted an investigational device exemption (IDE) to the DIAM Spinal Stabilization System for use in a clinical study.
Medtronic will be the first of three planned clinical trials in the U.S. and Europe. The DIAM System is designed to alleviate pain in degenerative stenosis patients. They suffer from radiating leg discomfort and moderate low back pain.
The initial Medtronic study will look for the safety and efficacy of the DIAM System after using to treat patients with degenerative stenosis.
Degenerative stenosis becomes noticeable by the gradual narrowing of the spinal canal, which results in pressure on the spinal cord or nerve roots.
The purpose of decompression surgery is to release excess pressure by creating more space in the spinal canal. Combined with decompression, the DIAM System could offer patients with leg and back pain a minimally invasive alternative to spinal fusion.
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DIAM Spinal Stabilization System gets approval for clinical study
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