FDA Grants IDE For Medtronic's DIAM(TM) Spinal Stabilization System
BY ARIELLA P. GOLOMB, MD, JULY 10, 2006
Medtronic, Inc. announced today that the FDA granted an investigational device exemption (IDE) to the DIAM(TM) Spinal Stabilization System for use in a clinical safety and effectiveness study. The DIAM System will be measured against posterior lumbar interbody fusion, the current standard of care in patients with degenerative stenosis. This is the first of three studies planned in the US and Europe.
The DIAM System is part of Medtronic's Minimal Access Spinal Technology (MAST TM) product line. Combined with decompression, the DIAM System could offer patients with leg and back pain a minimally invasive alternative to spinal fusion. According to Medtronic, the DIAM System is the only non-rigid interspinous spacer under clinical investigation, and since 1997, more than 20,000 surgeries have already been successfully performed in Europe, Asia and Latin America using the DIAM System.
Ahead of Medtronic in the US market for interspinous spacers is St. Francis Medical, who received FDA approval for its X STOP Interspinous Process Decompression (IPD) System back in November, 2005, but only after facing regulatory hurdles from FDA Orthopedic and Rehabilitation Device Panel.
