Medtronic Announces Comprehensive U.S. Launch of New InterStim™ Micro Neurostimulator
August 05 2020 - 7:00AM
Medtronic plc (NYSE:MDT), the global leader in medical technology,
today announced that its recently FDA-approved InterStim™ Micro
neurostimulator for sacral neuromodulation (SNM) therapy is now
available in the United States. Cleveland Clinic performed the
first patient implant in the nation with the new device.
Sacral neuromodulation sends electrical impulses
to the sacral nerves located in the lower back to improve bladder
and bowel control. Unlike oral medications that target the muscular
component of bladder control, SNM offers control of symptoms
through direct modulation of the nerve activity, normalizing the
communication between the bladder and the brain.1,2
"Effective long-term bladder and bowel control is
needed for almost 55 million adults3,4,5,6 in the United
States who often experience regular accidents and/or frequency
issues that are associated with overactive bladder (OAB) and fecal
incontinence (FI),” said Sandip Vasavada, M.D., professor at the
Glickman Urological and Kidney Institute and section head Female
Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic. “A
new FDA-approved option for these patients is a step
forward.” Dr. Vasavada discloses compensation for
speaker/trainer/educator activities.
About InterStim Micro
- At 2.8 cm3, it is 50% smaller than the market’s other
rechargeable SNM device, making it the world’s smallest.
- Allows patients to choose how and when they want to charge
their device —from a quick charge once a week, or as infrequent as
once per month, depending on the patient’s preference or device
settings.
- Features SureScan™ MRI technology, which enables full-body MRI
conditional scans.
- Does not require impedance checks prior to an MRI scan,
providing more efficiency in patient care versus the other SNM
system on the market.
- Can recharge from zero to 100% in less than an hour, making it
the fastest battery available.
- Reduces the need for battery replacement surgeries due to its
life of 15 years.
“Patients unfortunately limit their lives
socially, professionally and personally due to OAB and FI,” said
Howard Goldman, M.D., professor and vice chairman of Quality and
Patient Safety, Glickman Urological and Kidney Institute, Cleveland
Clinic. “With this newly FDA-approved device, we have a new option
and can offer more patients sacral neuromodulation therapy and
improve their quality of life.” Dr. Goldman discloses
compensation for speaker/trainer/educator and consulting
activities.
“OAB and FI patients want to live a life without
limits, and we designed our new rechargeable SNM system to advance
this reality,” said Brooke Story, vice president and general
manager of the Pelvic Health& Gastric Therapies business, which
is part of the Restorative Therapies Group at Medtronic. “We
created our entire InterStim portfolio in partnership with
physicians backed by a 25-year track record of experience in sacral
neuromodulation including over 325,000 implanted patients, 5-year
clinical data and more than 1,000 peer-reviewed articles. We are
confident our InterStim systems give patients and physicians the
best choice in SNM therapy.”
About MedtronicMedtronic 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 90,000 people worldwide, serving physicians, hospitals and
patients in more than 150 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-
1 Leng WW, Morrisroe SN. Sacral nerve
stimulation for the overactive bladder. Urol Clin N Am.
2006;33:491-501.
2 Kenefick NJ, Emmanuel A, Nicholls RJ.
Effect of sacral nerve stimulation on autonomic nerve function.
British Journal of Surgery. 2003;90:1256-1260.
3 Stewart WF, et al. Prevalence and burden of
overactive bladder in the United States. World J Urol. 2003
May;20(6):327-336.
4 United Nations, Department of Economic and
Social Affairs, Population Division (2011). World Population
Prospects: The 2010 Revision, CD-ROM Edition.
5 Whitehead WE, Borrud L, Goode PS, et al.
Pelvic floor disorders network. Fecal incontinence in US adults:
epidemiology and risk factors. Gastroenterology. 2009;137:
512-517
6 United States Quick Facts. United States
Census Bureau Web site. Available at:
https://www.census.gov/quickfacts/table/ PST045215/00. Accessed
July 19, 2016.
David T. YoungPublic Relations+1-774-284-2746
Ryan WeispfenningInvestor Relations+1-763-505-4626
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