FDA Approves Clinical Trial for Medtronic’s DIAM Spinal Stabilization System
MEMPHIS, Tenn. – Sept. 27, 2006 – Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration has granted an investigational device exemption (IDE) to the DIAM™ Spinal Stabilization System for use in a second U.S. clinical study. This prospective, randomized, controlled pivotal IDE clinical trial will attempt to prove the DIAM Spinal Stabilization System is superior to conservative care for patients with low back pain caused by degenerative disc disease (DDD).
The DIAM Spinal Stabilization System is designed to alleviate pain in DDD patients who suffer from low back pain in the lumbar region. It is the only non-rigid interspinous spacer currently under clinical investigation.
The study will take place at 20 sites around the U.S. and enroll more than 300 patients. The control group of non-operative treatment will include medication, physical therapy, patient education and spinal injections.
More then 65 million Americans suffer from lower back pain attributed to DDD, also called osteoarthritis. Degeneration in the vertebral discs is a normal part of the aging process. As the body ages, the discs in the spine dehydrate or dry out, and lose their ability to act as shock absorbers between the vertebrae. Pain occurs when the degenerating discs pinch and put pressure on the nearby nerve roots or spinal cord.
“This clinical trial is designed to show that the DIAM Spinal Stabilization System provides a new option for minimally invasive treatment of low back pain by providing stability, with the softness and flexibility thought to improve comfort and application,” said Mathew F. Gornet, M.D. “This may allow me to treat patients with a simple procedure and has the promise to dramatically improve my patients’ quality of life.”
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.
This study is one of three U.S. and European trials on the safety and effectiveness of the DIAM™ Spinal Stabilization System. Prospective patients can find additional information about DIAM™ and the clinical trials at www.back.com/clinicaltrial.
About the Spinal Business at Medtronic
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 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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