Medtronic Receives CE Mark for InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads
January 13 2020 - 9:00AM
Medtronic plc (NYSE:MDT) today announced it has received CE
Mark for its InterStim™ Micro neurostimulator and InterStim™
SureScan™ MRI leads — clearing the technologies for commercial sale
and clinical use in Europe. The availability of the new
technologies on January 15 will expand access to sacral
neuromodulation (SNM) therapy for thousands of potential European
patients by offering full-body MRI scan eligible,
lifestyle-friendly choices with either the InterStim Micro or
InterStim II neurostimulators.
InterStim Micro is a rechargeable device that
delivers sacral neuromodulation therapy to treat overactive bladder
(OAB), fecal incontinence (FI) and non-obstructive urinary
retention. It is 80% smaller than the existing recharge-free
InterStim II neurostimulator and could reduce the need for battery
replacement surgeries due to its life of 15 years. It also features
proprietary Overdrive™ battery technology — a battery with
virtually no loss in capacity over time1 — that provides
simple and rapid recharging. The SureScan leads, which will be used
in both the InterStim Micro system and in future implants of the
existing recharge-free InterStim II, are designed to allow for
full-body 1.5 and 3 Tesla MRI-conditional scans.
Between 4% and 8% of the world’s population —
almost 400 million people worldwide2 — suffer from
incontinence. In addition, at least half of patients with
pacemakers or neurostimulators will have a clinical indication for
an MRI examination over their lifetime3, and up to 23% of SNM
explants are currently due to the need for an MRI
scan4. Medtronic has treated more than 300,000 patients
with recharge-free InterStim systems and, now, the rechargeable
InterStim Micro and SureScan leads for the InterStim Micro and
InterStim II systems will allow even more patients to access the
therapy. In addition, Medtronic is the only company in Europe to
offer patients a choice between rechargeable and recharge-free
systems that are both full-body MRI-conditional.
“We’re excited our most recent technology advances
in sacral neuromodulation will allow physicians to treat more
patients who need relief from their symptoms,” said Brooke Story,
vice president and general manager of the Pelvic Health and Gastric
Therapies business, which is part of the Restorative Therapies
Group at Medtronic. “We pioneered this therapy 25 years ago in
partnership with physicians, and we have the only five-year data
for all indications to demonstrate its safety and efficacy. We know
from deep experience that it’s important the therapy accommodates
the lifestyle of the patient to produce the best outcome, and our
latest innovations will now offer them a lifestyle-friendly choice
in Medtronic SNM systems.”
OAB significantly impacts quality of life and
can negatively affect social activities, exercise and
intimacy.5,6 Many sufferers limit their lives socially,
professionally, and personally.7 However, as many as 45% who
suffer from symptoms do not seek treatment and as many as seven in
10 stop using medications within six months due to intolerable side
effects or unsatisfying results.7-10
“Effective long-term bladder and bowel control is
an under-met medical need for many who experience regular accidents
and/or frequency issues associated with OAB and FI," said Philip
E.V. Van Kerrebroeck, M.D., Ph.D., MMSc; professor of Urology,
Maastricht University Medical Centre, Maastricht, the Netherlands.
"The new capabilities offered by MRI-conditional InterStim II and
InterStim Micro will give patients the ability to choose a system
that is compatible with their lifestyle, and they can have an MRI
without being explanted. I’m excited because it allows me to offer
the trusted experience and support of Medtronic to help give my
patients their lives back.”
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-
- Medtronic data on file.
- About Incontinence. Global Forum on Incontinence website.
Available at: http://www.gfiforum.com/incontinence
- Kalin R, Stanton MS. Current clinical issues for MRI scanning
of pacemaker and defibrillator patients. Pacing Clin
Electrophysiol. 2005 Apr;28(4):326-8.
- Lloyd JC, Gill BC, Pizarro-Berdichevsky J, Goldman HB. Removal
of sacral nerve stimulation devices for magnetic resonance imaging:
what happens next? Neuromodulation. 2017;20(8):836-840.
- 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 national survey. Current Medical
Research and Opinion. 2007;23:65-76.
- Muller, N. "What Americans understand and how they are affected
by bladder control problems: highlights of recent nationwide
consumer research." Urol Nurs 2005;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.
Katie GenereuxPublic Relations+1-763-514-0162
Ryan WeispfenningInvestor Relations+1-763-505-4626
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