October 23, 2006
First Patient Enrolled in Medtronic’s Clinical Trial of the DIAM Spinal Stabilization System
The first patient to enter an FDA approved clinical trial designed to determine the safety and effectiveness of the DIAM™ Spinal Stabilization System has undergone successful implant surgery. Medtronic, Inc. (NYSE:MDT) announced today that the surgery was performed on Sept. 23, by J. Kenneth Burkus, M.D., of the Hughston Clinic in Columbus, Ga.
The DIAM System is designed for patients who have degenerative stenosis and who suffer predominantly from radiating leg discomfort and moderate low back pain. 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.
"The procedure went smoothly," said Burkus. "Following the posterior lumbar decompression, I inserted the DIAM System between the posterior spinous processes. I am hopeful that the DIAM System will offer patients with leg and back pain a minimally invasive treatment option."
Degenerative stenosis affects more than 250,000 U.S. patients each year. Stenosis 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 on the nerve by creating more space in the spinal canal. Combined with decompression, the DIAM System may offer pain relief for patients with leg and back pain through a minimally invasive alternative to spinal fusion.
The implant is placed between the spinous processes (the visible ridges of the back) and is designed to act as a shock absorber that reduces loads on the surrounding vertebrae. 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 first DIAM System surgery was performed by inventor Jean Taylor, M.D. of France in 1997. Since then, more than 25,000 surgeries have been successfully performed in Europe, Asia and Latin America using the DIAM System.
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. The 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.
Caution: Investigational device. Limited by Federal (United States) law to investigational use.