(PressMediaWire) MINNEAPOLIS, – Feb. 29, 2008 – Medtronic, Inc. (NYSE: MDT) recognizes the research published this week in the New England Journal of Medicine (NEJM)
showing that patients with a condition known as spinal stenosis, or a
narrowing of the spinal canal, showed substantially greater improvement
when treated surgically versus non-surgically. The results were part of
the Spine Patient Outcomes Research Trial (SPORT), a study conducted at
13 spine centers across the United States and sponsored by the National
Institutes of Health (NIH). At all evaluation points, patients in both
surgical and non-surgical groups showed improvement, however, the
surgery patients showed statistically significant improvement in pain,
function and disability scores, while non-surgical patients showed only
a moderate improvement.
The complete findings can be found at http://content.nejm.org/cgi/content/short/358/8/794
“The
SPORT results clearly favor traditional spine surgery as a great
therapy option for patients who want to get their lives back,” said
John H. Peloza, M.D. and medical director of the Center for Spine Care
in Dallas. “In fact, in all three cohorts of the
SPORT trial, surgery proved to be better than non-operative care for
relieving leg and back pain.”
Patients with a history of at
least 12 weeks of symptoms for spinal stenosis without
spondylolisthesis were enrolled in either a randomized cohort or an
observational cohort. Treatment was either a standard posterior
decompressive laminectomy surgery or usual nonsurgical care. The
primary outcomes were measures of bodily pain and physical function on
the Medical Outcomes Study 36-item Short-Form General Health Survey
(SF-36) and the modified Oswestry Disability Index at six weeks, three
months, six months, and one- and two-years. For patients treated with
surgery, symptom relief was seen as early as six weeks and continued
throughout the two-year study period. The patients treated
nonsurgically reported only moderate improvements during the two-year
study period.
More than 600 patients were enrolled in this part
of the SPORT study with 289 patients enrolled in the randomized cohort
and 365 patients enrolled in the observational cohort. The as-treated
analysis, which combined both cohorts and was adjusted for potential
confounders (nonadherence to the study protocol), showed a significant
advantage for surgery by three months for all primary outcomes; these
changes remained significant at two years.
SPORT was specifically
designed to compare three surgical therapies to non-surgical treatments
for patients with intervertebral disc herniation, spinal stenosis and
degenerative spondylolisthesis. The NEJM article follows an
earlier article it published on SPORT in May 2007, which shows patients
suffering from spinal stenosis with degenerative spondylolisthesis also
had better outcomes after a surgical intervention involving spinal
fusion. In addition, results of the SPORT study involving patients with
intervetebral disc herniations were published in The Journal of the American Medical Association
in 2006. That report showed that patients fared better than
non-surgical patients when it came to treating disc herniation in the
lumbar spine.
In addition to the surgical techniques described in
the SPORT trial, newer, less invasive interventions have been proven to
bring patients with spinal stenosis better results than non-operative
care.
Medtronic’s X-STOP® Interspinous Process Decompression
(IPD®) System was approved in 2005 for use in the United States to
treat patient symptoms, such as pain or numbness in the legs and back,
due to lumbar spinal stenosis. The clinical trial supporting this
approval demonstrated that many patients receiving the X-STOP IPD
implant experience rapid relief of their spinal stenosis symptoms,
improved physical function, and increased satisfaction, leading to
overall treatment success. During the X-STOP IPD System procedure
there is usually no tissue or bone removal, maintaining the natural
anatomy of the spine. Further, while the traditional laminectomy
patients in the SPORT trial did well, they also spent more than three
days, on average, in the hospital, while losing an average of 314 ml of
blood and spending 120 minutes in an operating room.1
In
addition, nine percent of the randomized patients who received surgery
experienced an intraoperative complication, the most common being dural
tears or spinal fluid leaks. The X-STOP IPD System patients, as shown
in another clinical study comparing patients treated with the X-STOP
IPD System to patients receiving non-operative care, were in the
operating room for an average of 54 minutes and lost, on average 46 ml
of blood with only three percent of patients experiencing
intraoperative complications.2
“The SPORT study
provides compelling evidence that surgically treated patients suffering
from spinal stenosis and neurogenic claudication have improved outcomes
over those treated non-operatively,” said Clifford Tribus, M.D., an
orthopaedic surgeon at the University of Wisconsin.
“With modern,
less-invasive techniques like the X-STOP IPD System, we can perform the
surgery in an out-patient setting and the patient can go home in the
same day.”
Information on the Spine Patient Outcome Research
Trial, spinal stenosis, patient testimonials and spinal surgery options
can be found at www.back.com and www.insidespine.com.
About the Spinal Business at Medtronic
The
Spinal business at Medtronic is based in Memphis, Tenn. It 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, dental 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 27, 2007. Actual results may differ materially from anticipated
results.
1Weinstein JN, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med 2008;358:794-810.
2Zucherman,
et al. SPINE Volume 30, Number 12, pp 1351–1358 A Multicenter,
Prospective, Randomized Trial Evaluating the X STOP Interspinous
Process Decompression System for the Treatment of Neurogenic
Intermittent Claudication Two-Year Follow-Up Results
-end-
SOURCE: MEDTRONIC
