FDA Approves Clinical Trial For Medtronic’s DIAM™ Spinal Stabilization System
MEMPHIS, TENN. – July 10, 2006 – Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) 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 U.S. and Europe. 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. 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.
The DIAM System, part of Medtronic’s Minimal Access Spinal Technology (MAST™) product line, will be measured against posterior lumbar interbody fusion, the current standard of care for patients undergoing surgery for spinal stenosis. The DIAM System study is the latest initiative in Medtronic’s efforts to provide a clinically robust and proven portfolio of Dynamic Spinal Stabilization products.
The first DIAM System surgery was performed by inventor Jean Taylor, M.D. of France in 1997. Since then, more than 20,000 surgeries have been successfully performed in Europe, Asia and Latin America using the DIAM System. The safety and effectiveness of the DIAM System must be demonstrated in the U.S. prior to FDA approval.
Prospective patients can find additional information on inclusion and exclusion criteria in this clinical trial to test the safety and effectiveness of the system at www.back.com/clinicaltrial or www.maturespine.com/clinicaltrial.
Caution: The DIAM System is an investigational device and exclusively for clinical investigation in the United States.
About Medtronic’s Spinal Business
Medtronic’s spinal business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic’s spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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