Medtronic to start DIAM spinal stabilization trials

By Elaine Rigoli

Tampa, Fla., July 10 - Medtronic, Inc. said the Food and Drug Administration has granted an Investigational Device Exemption to the DIAM spinal stabilization system for use in a clinical study.

This approval will allow Medtronic to begin the first of three planned clinical trials in the United States and Europe.

The company said the DIAM system is designed to alleviate pain in degenerative stenosis patients who suffer predominantly from radiating leg discomfort and moderate low-back pain and is the only non-rigid interspinous spacer under clinical investigation.

The initial Medtronic study will examine the safety and effectiveness of the DIAM system when used to treat patients with degenerative stenosis, marked by the gradual narrowing of the spinal canal, resulting in pressure on the spinal cord or nerve roots.

Degenerative stenosis affects more than 250,000 U.S. patients each year, according to a news release.

Medtronic, based in Minneapolis, develops medical technology products.

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