Medtronic Inc. announced that it has received an investigational device exemption for its DIAM™ Spinal Stabilization System for use in a clinical study. This allows Medtronic to begin the first of three clinical trials in the US and Europe. The DIAM System was developed to reduce pain in degenerative stenosis patients who predominantly suffer from “radiating leg discomfort and moderate low back pain and is the only non-rigid interspinous spacer under clinical investigation.”
Here’s more about the study and the device:
The initial Medtronic study will examine the safety and effectiveness of the DIAM System when used to treat patients with degenerative stenosis. Degenerative stenosis is a common condition in the aging process, 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. Stenotic spine patients with radiating leg pain or numbness typically undergo decompression surgery alone. Patients with both leg and back pain normally have a decompression surgery with fusion. 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.
The implant is placed between the spinous processes (the visible ridges of the back) to act as a shock absorber that reduces loads on the surrounding vertebrae and restores the natural function of the joint. The core of the DIAM System is made of silicone, while the outer mesh and tethers are made of medical-grade polyester. The flexible properties of the DIAM materials may also protect the integrity of the spinous process.