2006-10-26

Short and Long-Term Efficacy of Spinal Stabilisation System Investigated in Patients With Lower Back Pain


Tolochenaz, Switzerland (ots/PRNewswire) - A new study announcedtoday by Medtronic will investigate the short and long-term benefitsof adding a spinal stabilisation system to a standard herniectomyprocedure in patients with spinal disc herniation. The study is thefirst randomised control trial to assess the clinical benefit andpatient perception of the relief of lower back pain in patients withspinal disc herniation, comparing a standard herniectomy versus aherniectomy supplemented with the DIAM(TM) Spinal StabilisationSystem.

"This new study is crucial to determine whether a spinalstabilisation system can help offer faster recovery time and reducepostoperative pain to patients with lower back pain undertaking aherniectomy and hence prevent or delay the need for spinal fusion,"stated Dr. Ferdinand Krappel, an orthopaedic surgeon withMedizinisches Zentrum Kreis Hospital in Aachen, Germany, and aleading investigator of the DIAM study. "Compared to spinal fusion,this procedure is minimally invasive and it maintains the surgicalsite for future procedures if and when required."

It is estimated that more than 22 million people age 20 and oldersuffer from chronic back pain in Western Europe. One-third of theseadults show evidence of herniated disc. Spinal disc herniation isalso known as a slipped, ruptured or torn disc, and consists in arupture of the spinal disc often occurring as a result of aging.

This multi-centre study expects to enroll 268 patients at 20centres in six countries, including Belgium, Germany, Italy, Spain,Switzerland, and the United Kingdom. The study is the third of threeplanned randomised control trials investigating the benefits of theDIAM Spinal Stabilisation System in more than 1,000 patients in theUnited States and in Europe. The European trial endpoints includeback pain relief at six months and reduction of disability at 12months.

The herniectomy procedure takes approximately one hour and usuallyrequires two to three days of hospitalisation. During the operation,the spinal stabilisation system is placed between the spinousprocesses (the visible ridges of the back) and is designed to act asa shock absorber that reduces loads on the surrounding vertebrae. Thecore of the DIAM System is made of silicone, while the outer mesh andtethers are made of medical-grade polyester. The flexible propertiesof the DIAM materials may also protect the integrity of the spinousprocess.

According to Lionel Hadjadjeba, vice president of the Spinal,Biologics and Navigation business at Medtronic, "Medtronic plays aleading role in the research on new device therapy for patients withchronic back pain, and learning more about the DIAM SpinalStabilisation System will enable us to continue bringing therapies tomarket."

Back pain is one of the most common reasons for chronic disabilityand incapacity in the Western world.

About the Spinal Business at Medtronic

Medtronic's spinal business, based in Memphis, Tenn., is theglobal leader in today's spine market and is committed to advancingthe treatment of spinal conditions. The spinal business collaborateswith world-renowned surgeons, researchers and innovative partners tooffer state-of-the-art products and technologies for neurological,orthopedic and spinal conditions. Medtronic is committed todeveloping affordable, minimally invasive procedures that providelifestyle friendly surgical therapies. More information about thecompany and its spinal treatments can be found atwww.medtronicspinal.com and its patient-education Web sites,www.back.com, www.iscoliosis.com, www.maturespine.com andwww.necksurgery.com.

About Medtronic

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 aroundthe world.

Any forward-looking statements are subject to risks anduncertainties such as those described in Medtronic's Annual Report onForm 10-K for the year ended April 28, 2006. Actual results maydiffer materially from anticipated results.

ots Originaltext: Medtronic IncIm Internet recherchierbar: http://www.presseportal.de

Contact:Contacts: Yvan Deurbroeck, Public Relations, +41-21-802-7574

Medtronic Inc

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Short and Long-Term Efficacy of Spinal Stabilisation System Investigated in Patients With Lower Back Pain

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