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

Tolochenaz, Switzerland (ots/PRNewswire)

A new study announced
today by Medtronic will investigate the short and long-term benefits
of adding a spinal stabilisation system to a standard herniectomy
procedure in patients with spinal disc herniation. The study is the
first randomised control trial to assess the clinical benefit and
patient perception of the relief of lower back pain in patients with
spinal disc herniation, comparing a standard herniectomy versus a
herniectomy supplemented with the DIAM(TM) Spinal Stabilisation
System.
"This new study is crucial to determine whether a spinal
stabilisation system can help offer faster recovery time and reduce
postoperative pain to patients with lower back pain undertaking a
herniectomy and hence prevent or delay the need for spinal fusion,"
stated Dr. Ferdinand Krappel, an orthopaedic surgeon with
Medizinisches Zentrum Kreis Hospital in Aachen, Germany, and a
leading investigator of the DIAM study. "Compared to spinal fusion,
this procedure is minimally invasive and it maintains the surgical
site for future procedures if and when required."
It is estimated that more than 22 million people age 20 and older
suffer from chronic back pain in Western Europe. One-third of these
adults show evidence of herniated disc. Spinal disc herniation is
also known as a slipped, ruptured or torn disc, and consists in a
rupture of the spinal disc often occurring as a result of aging.
This multi-centre study expects to enroll 268 patients at 20
centres in six countries, including Belgium, Germany, Italy, Spain,
Switzerland, and the United Kingdom. The study is the third of three
planned randomised control trials investigating the benefits of the
DIAM Spinal Stabilisation System in more than 1,000 patients in the
United States and in Europe. The European trial endpoints include
back pain relief at six months and reduction of disability at 12
months.
The herniectomy procedure takes approximately one hour and usually
requires two to three days of hospitalisation. During the operation,
the spinal stabilisation system 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.
According to Lionel Hadjadjeba, vice president of the Spinal,
Biologics and Navigation business at Medtronic, "Medtronic plays a
leading role in the research on new device therapy for patients with
chronic back pain, and learning more about the DIAM Spinal
Stabilisation System will enable us to continue bringing therapies to
market."
Back pain is one of the most common reasons for chronic disability
and incapacity in the Western world.
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.
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 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.

Contact:

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