Medtronic Announces First DIAM™ Spinal Stabilization System Surgeries in European Post Market Study
TOLOCHENAZ, Switzerland. – Dec. 18, 2006 – Medtronic, Inc. (NYSE: MDT) today announced the enrollment of the first two patients in the European post market clinical study using the DIAM™ Spinal Stabilization System. The first two surgeries were performed on Nov. 24 by Dr. Gianluca Maestretti of the Hôpital Cantonal Fribourg, Switzerland, and Dr. Ferdinand Krappel of the Medizinisches Zentrum Kreis Aachen, Wuerselen, Germany.
These surgeries are part of a randomized, controlled clinical trial that is comparing Medtronic’s DIAM Spinal Stabilization System to a standard disc herniectomy. The DIAM Spinal Stabilization System is currently affixed with a CE Mark and available for distribution in the European market, but not approved for use in the U.S. Evidence collected from this trial will be used to improve treatment decisions for better patient outcomes. Patients are being randomized into either an investigational group, consisting of a herniectomy supplemented by the DIAM Spinal Stabilization System, or a control group, consisting of patients who will undergo a standard herniectomy. Herniectomy is the standard of care for addressing leg pain caused by disc herniation. When combined with a standard herniectomy, the DIAM Spinal Stabilization System may result in a therapy solution that provides both leg and back pain relief for the patient.
The DIAM Spinal Stabilization System implant is placed between the spinous processes (the visible ridges of the back) and is designed to act as a shock absorber that reduces weight on the surrounding vertebrae. The core of the DIAM System is made of medical-grade silicone, while the outer mesh and tethers are made of polyester. The flexible properties of the DIAM System materials may also protect the integrity of the spinous process.
Patients will be evaluated for differences in pain relief, physical disability and quality of life as well as further progression of their disc disease. The study is assessing the short and long-term effectiveness and patient perception of benefit with the use of the DIAM Spinal Stabilization System in the treatment of complex disc disease. This is a multicentre study with 20 investigational centres within Western Europe.
Additional information on back pain and the DIAM Spinal Stabilization System can be found at www.back.com/clinicaltrial.
About the Spinal Business at Medtronic
The Spinal business at Medtronic, 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.
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- Medtronic, Inc.
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