2012-10-04 15:45:57 -
InSite Study Results Show Efficacy and Quality of Life Advantages with
InterStim® System
MINNEAPOLIS - October 4, 2012 - The first-ever study to compare the clinical
benefits of Medtronic, Inc. (NYSE: MDT) sacral neuromodulation (SNM) with
standard medical treatment (oral medication) in less-severe overactive bladder
(OAB) patients - defined as those failing at least one previous OAB medication -
found SNM, delivered by the Medtronic InterStim® system, to be associated with
superior efficacy and quality of life (QOL) versus medication alone.(1,2)
Results of the study, which represents a less-severe segment of SNM eligible
subjects than have been previously studied in a multicenter trial, were
presented today at the American Urogynecologic Society (AUGS) annual scientific
meeting in Chicago.
An intent-to-treat analysis of results at six months found that 61 percent of
patients who received sacral neuromodulation (n=70) reported significant
improvement in OAB symptoms (>=50 percent improvement in average leaks/day, or
>=50 percent improvement in voids/day, or a return to normal voiding frequency
[<8 voids/day]) compared to 42 percent of patients who received standard medical
treatment (n=77, p<0.05).
Favorable results were also reported by patients in the as-treated population,
which compared the responses of patients actually receiving the Medtronic
InterStim system (n=51) to those receiving standard medical treatment (n=73). A
significantly greater therapeutic OAB success rate was reported in 76 percent of
as-treated study participants with SNM delivered via the InterStim system
compared with 49 percent of patients receiving standard medical treatment
(p<0.01).
Results also showed that 71 percent of as-treated SNM subjects with urinary urge
incontinence (n=38) reported improvement in OAB symptoms (>=50 percent
improvement in average leaks/day), while 47 percent of subjects treated with SMT
(n=57) showed improvement (p<0.05). Complete urinary continence was achieved in
40 percent of SNM subjects and 21 percent of SMT subjects. Of the study
participants with urgency-frequency issues, 61 percent of SNM subjects (n=33)
achieved normal voiding patterns (<8 voids/day) compared to 37 percent in the
SMT group (n=46, p<0.05).
Additionally, an as-treated analysis of an OAB quality of life questionnaire
showed that patients receiving SNM had significantly greater improvements in OAB
quality of life at six months compared to SMT, including levels of concern,
coping ability, sleep habits, social functioning, total health-related quality
of life and a measure of how much urinary symptoms interfere with everyday
activities (all p<0.001). Average improvement in the total health-related
quality of life score at six months in SNM was more than three times greater
than that in SMT (40.1 vs. 12.5).
The prospective, multicenter, post-approval study included patients with
bothersome OAB symptoms, including urinary urge incontinence or urgency-
frequency, who had unsuccessfully used at least one OAB medication. For this
analysis, 147 study patients were randomized to receive either sacral
neuromodulation (n=70) or standard medical treatment with OAB medication
(n=77). Of the 70 patients in the SNM group, 51 had the InterStim system
implanted after undergoing successful test stimulation. SNM trial participants
were not allowed to take any OAB medications.
"The InterStim system is a well-established treatment option for patients with
refractory overactive bladder symptoms, and this study confirms the therapy is
effective," said Steven Siegel, M.D., InSite study lead investigator and
director of the Metro Urology Centers for Female Urology and Incontinence in
Woodbury, MN. "These results also show that the InterStim system provides
significant quality of life improvements in less-severe overactive bladder
patients than previously studied."
To date, more than 125,000 people worldwide have received Medtronic's InterStim
system. The system delivers mild electrical pulses to the sacral nerves through
a thin wire lead and a neurostimulator about the size of a stopwatch, which is
implanted under the skin in the lower back near where the sacral nerves are
located. The therapy is reversible - the system can be turned off or
surgically removed at any time - and it is FDA approved for MRI head scans under
specific conditions.³ After an extensive clinical evidence review, sacral
neuromodulation was recently labeled a "recommendation" for refractory
idiopathic OAB patients by the American Urological Association's OAB Guidelines
Panel, based on evidence that the clinical benefits outweigh the risks.
"The InSite study results are an important input into the growing body of
evidence about the standard of care for overactive bladder management," said
Cindy Kent, vice president and general manager, gastro/urology therapies at
Medtronic. "The data clearly demonstrate that InterStim therapy is effective in
helping patients manage their symptoms and enjoy their lives."
In safety analysis, 23.7 percent of patients randomized to receive sacral
neuromodulation had device-related adverse events and 26.0 percent of patients
randomized to receive standard medical therapy had OAB medication-related
adverse events. The most common device-related adverse events were implant site
pain (8.5 percent), lead migration (3.4 percent) and infection (3.4 percent).
Researchers reported a low incidence of serious adverse events: 7.8 percent for
sacral neuromodulation and 5.3 percent for standard medical therapy. There were
no unanticipated device-related adverse events and there were no differences
between the two groups for any individual adverse event or for any serious
adverse events.
Additional information about Medtronic sacral neuromodulation with the InterStim
system can be found at www.everyday-freedom.com.
MEDTRONIC'S LEADERSHIP IN NEUROMODULATION
Medtronic developed and leads the field of neuromodulation, the targeted and
regulated delivery of electrical pulses and pharmaceuticals to specific sites in
the nervous system. The company's Neuromodulation business includes
neurostimulation and implantable, targeted drug delivery systems for the
management of chronic pain, common movement disorders, spasticity and urologic
and gastrointestinal disorders.
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 periodic reports on file with the Securities and
Exchange Commission.
-end-
1. Results of a prospective, randomized, multicenter study evaluating the
safety and efficacy of InterStim Therapy at 6-month follow-up in subjects
with symptoms of overactive bladder. Steven Siegel, Jason Bennett, Jeffrey
Mangel, Craig Comiter, Samuel Zylstra, Erin Bird, Tomas L. Griebling, Tony
Pinson, Daniel Culkin, and Suzette Sutherland. AUGS 33rd Annual Scientific
Meeting. Chicago, IL
2. Evaluation of quality of life improvements at six months in subjects with
overactive bladder randomized to InterStim® Therapy implant vs. standard
medical therapy. Jeffrey Mangel, Jason Bennett, Craig Comiter, Samuel
Zylstra, Erin Bird, Tomas L. Griebling, Tony Pinson, Daniel Culkin, Suzette
Sutherland, Steven Siegel. AUGS 33rd Annual Scientific Meeting. Chicago, IL
3. If a patient is implanted with an InterStim II model 3058 neurostimulator or
an eligible serial number of an InterStim model 3023 neurostimulator (when
implanted as a system including a neurostimulator, lead, and extension as
applicable), MRI examinations of the head only may be safely performed under
specific conditions. Refer to the labeling prior to an MRI head scan.
Contacts:
Justin Ihle
Public Relations
+1-763-526-0911
Jeff Warren
Investor Relations
+1-763-505-2696
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originality of the information contained therein.
Source: Medtronic, Inc. via Thomson Reuters ONE
[HUG#1646551]
