Five-Year Data Demonstrate InterStim(TM) Therapy Offers Sustained Long-Term Efficacy and Quality of Life Improvements for Ove...
July 17 2017 - 9:00AM
The InterStim
System is the Only Proven, Long-Term Sacral Neuromodulation
Solution for Overactive Active Bladder
DUBLIN - July 17, 2017 -
Medtronic plc (NYSE: MDT) today announced that the InterStim(TM)
system, which provides sacral neuromodulation therapy, offers
sustained long-term efficacy and quality of life improvements for
overactive bladder (OAB) at five years.1 Results of
the InSite study, which were published online in the Journal of Urology,1 found that 82
percent of patients had therapeutic success (defined as a greater
than 50 percent improvement in symptoms) at five years and
sustained quality of life improvements.
"Effective long-term bladder control is critical
because OAB is a chronic condition that significantly impacts all
aspects of a person's quality of life, including confidence,
activities and intimacy," said Steven Siegel, M.D., primary
investigator and director, Metro Urology Centers for Female Urology
and Continence Care, Minneapolis, Minn. "Many struggle to find
long-term relief and these results, which show the InterStim system
offers sustained long-term efficacy, meaningful symptom reduction
and quality of life improvements, offer new hope for those who
suffer."
The prospective InSite study evaluated the
efficacy and safety of the InterStim system at five-years in
patients with bothersome OAB symptoms, who had failed or could not
tolerate more conservative treatments, including urinary urge
incontinence (UI) and/or urgency-frequency (UF). The five-year
results include:1
-
The overall therapeutic success rate was 82
percent using the completers analysis (subjects with data at
baseline and each follow-up) and 67 percent using the modified
completers analysis (subjects who either had a baseline and
follow-up evaluation or withdrew early due to device-related
reasons and are considered failures)
-
Forty-five percent of patients with UI had
complete continence
-
UI patients had an average reduction of 2 leaks
per day (p<0.0001) and UF patients had a mean reduction of 5.4
voids per day (p<0.0001)
In addition, patients experienced sustained
quality of life improvements measured using the ICIQ-OABqol
questionnaire (p<0.0001) that were three times greater than what
is considered clinically significant
The InSite study demonstrated that the InterStim
system was a safe option for OAB sufferers. The most common
device-related adverse events were undesirable change in
stimulation, implant site pain and ineffectiveness.1
The study reported only one serious device-related adverse event
associated with the InterStim system.1 Implanting an
InterStim system has risks similar to any surgical procedure.
"The InterStim system has been an important
treatment option for 20 years and is the only sacral
neuromodulation treatment with five-year clinical data
demonstrating sustained, long-term efficacy for the treatment of
both OAB and fecal incontinence," said Linnea Burman, vice
president and general manager of the Pelvic Health & Gastric
Therapies business, part of the Restorative Therapies Group at
Medtronic. "These data should give physicians and patients
confidence that relief and restored quality of life are possible
and we hope this will help encourage the many still suffering from
bothersome OAB symptoms to seek help."
About Overactive
Bladder
The number of OAB patients is immense and increasing - more than 37
million Americans, or nearly 1 in 6 suffer - OAB is more common
than diabetes or asthma.2,3,4,5 The
condition significantly impacts quality of life, and can negatively
affect social activities, exercise and cause disruptive nighttime
voiding.6,7 Many
sufferers are frustrated and embarrassed and limit their lives
socially, professionally, and personally.8 However, 4.5
out of ten don't seek treatment and as many as seven in 10 stop
using medications within six months due to intolerable side effects
or unsatisfying results.9,10,11
Evidence points to OAB being caused by a
miscommunication between the bladder and brain.12
InterStim therapy uses neuromodulation, or gentle nerve
stimulation, to normalize the brain-bladder communication pathway.
InterStim is thought to restore bladder function by targeting the
sacral nerves to help alleviate symptoms. Restore is defined as
>=50 percent reduction in dysfunctional voiding symptoms from
baseline.
About Medtronic InterStim Therapy
for Bladder and Bowel Control
Medtronic is the first and leading provider of neuromodulation
solutions for bladder and bowel control issues. Sacral
neuromodulation therapy delivered by the InterStim system was first
approved twenty years ago in 1997 and has helped more than 250,000
patients worldwide. For important safety information please visit
www.medtronic.com/interstimsafety.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 91,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
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. Actual results may differ materially from
anticipated results.
-end-
References:
- Siegel, S., Noblett, K., et al. (2017). " Five
Year Follow-up Results of a Prospective, Multicenter Study in
Overactive Bladder Subjects Treated with Sacral Neuromodulation." J
Urol. http://dx.doi.org/10.1016/j.juro.2017.07.010.
- Stewart WF, J.B. Van Rooyen, et al. (2003).
"Prevalence and burden of overactive bladder in the United States."
World J Urol 20(6): 327-336.
- United Nations, Department of Economic and Social
Affairs, Population Division (2011). World Population Prospects:
The 2010 Revision, CD-ROM Edition.
-
Adult self-reported lifetime asthma
prevalence rate (percent) and prevalence (number) by state or
territory: BRFSS 2010. Centers for Disease Control and Prevention
website. http://www.cdc.gov/asthma/brfss/2010/lifetime/tableL1.htm.
Updated August 27, 2012. Accessed January 25, 2016.
-
National diabetes statistics report,
2014. National Diabetes Information Clearinghouse website.
http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.
Updated 2014. Accessed January 25, 2016.
- Coyne, K. S., C. Payne, et al. (2004). "The
impact of urinary urgency and frequency on health-related quality
of life in overactive bladder: results from a national community
survey." Value Health 7(4): 455-463.
- Cartwright, R., S. Srikrishna, et al. (2011).
"Validity and reliability of patient selected goals as an outcome
measure in overactive bladder." Int Urogynecol J 22(7):
841-847.
- Dmochowski RR, Newman DK. Impact of overactive
bladder on women in the United States: results of a nationall
survey. Current Medical Research and Opinion. 2007;23:65-76.
- Muller, N. (2005). "What Americans understand and
how they are affected by bladder control problems: highlights of
recent nationwide consumer research." Urol Nurs 25(2):
109-115.
- Yu YF, Nichol MB, Yu AP, et al. Persistence and
adherence of medications for chronic overactive bladder/urinary
incontinence in the California Medicaid Program. Value in Health.
2005;8(4)495-505.
- Leede Research, "Views on OAB: A Study for the
National Association of Continence." December 16, 2015.
- Leng WW, Morrisroe SN. Sacral nerve stimulation
for the overactive bladder. Urol Clin N Am. 2006;33:491-501.
Contacts:
Lindsey Dickinson
Public Relations
+1-763-526-9452
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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