Medtronic SureTune(TM)3 Earns CE Mark for Deep Brain Stimulation Therapy
June 28 2017 - 7:00AM
Data Presented at
the 17th Quadrennial Meeting of the World Society for Stereotactic
and Functional Neurosurgery in Berlin
DUBLIN and BERLIN - June 28, 2017
- Medtronic plc (NYSE: MDT) today announced it has received CE
(Conformité Européenne) Mark for SureTune(TM)3 software for deep
brain stimulation (DBS). SureTune3 provides patient-specific
visualization of lead location and simulated volume of neural
activation to help physicians make decisions on how to program - or
tune - their patient's DBS therapy.
Medtronic DBS therapy has CE Mark approval for
diseases such as Parkinson's disease and treats symptoms such as
tremor via a surgically implanted medical device, similar to a
cardiac pacemaker, that delivers mild electrical pulses to
precisely targeted areas of the brain. Electrical stimulation of
these areas normalizes the brain circuits that control symptoms.
More than 10 million people worldwide are living with Parkinson's
disease.1
SureTune3's advancements streamline the
physician's workflow and allow StealthStation(TM) surgical planning
information to be imported. SureTune3 also contains a 3D deformable
atlas to allow physicians to more precisely define anatomical
structures, or the exact region in the brain that must be
stimulated to alleviate symptoms. The SureTune3 system is fully
downloadable with the option to work over a hospital's server so
clinical multidisciplinary teams can work flexibly. SureTune3 is
currently not approved in the United States.
Data on SureTune3 were presented today by
Professor Jens Volkmann, MD, PhD, FEAN, chairman and professor of
neurology in the University Clinic of Würzburg at the World Society
for Stereotactic and Functional Neurosurgery Meeting currently
ongoing in Berlin, Germany. At the congress, he explained how
SureTune3 is helping his team with patient management. "With
SureTune3, I can integrate all patient data - both planning and
procedure - which allows for more personalized management of each
case," said Prof. Volkmann. "The improved software allows me to
accurately visualize each DBS patient's stimulation settings."
Using this approach, clinical programming experience,
patient-specific visualization of simulated volume of neural
activation and stereotactic planning will form an integrated
workflow. Prof. Volkmann also presented research using SureTune3
which may provide further insight into how individual neural
activation maps may be used.
Medtronic DBS therapy has CE Mark approval for
Parkinson's Disease, Dystonia, Essential Tremor, OCD and Epilepsy
and is the only DBS complete portfolio that, under specific
conditions, is full body MR conditional and can be left on during
an MRI scan.2
"The latest innovations to our SureTune software
take the Medtronic DBS solution to the next level: beyond our
former innovations of MR conditional devices and beyond the
standard visualization of the stimulation field," said Brett Wall,
senior vice president and president of the Brain Therapies
division, which is part of the Restorative Therapies Group at
Medtronic. "Medtronic has been leading the way in DBS therapy for
more than 30 years and we will continue to explore and develop new
innovations for both the patients and physicians who rely on
them."
About Medtronic DBS
Therapy
DBS therapy uses a surgically implanted medical device, similar to
a cardiac pacemaker, to deliver electrical stimulation to precisely
targeted areas of the brain to reduce some of the most disabling
motor symptoms associated with Parkinson's disease, including
shaking, stiffness and movement difficulties. Medtronic DBS
complete portfolio is the first approved for full-body MRI scans
under specific conditions.2 Since 1997,
more than 150,000 Medtronic DBS devices have been implanted
worldwide.
DBS therapy is currently approved in many
locations around the world, including the United States and Europe,
for the treatment of the disabling symptoms of essential tremor and
recent and longer-standing Parkinson's disease. Under a
Humanitarian Device Exemption (HDE) in the United States, the
therapy can also be used to treat chronic intractable primary
dystonia. In Europe, Canada and Australia, DBS therapy is licensed
for the treatment of refractory epilepsy. DBS therapy is also
approved for the treatment of severe, treatment-resistant
obsessive- compulsive disorder in the European Union and Australia,
and in the United States under an HDE.
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 88,000 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-
1. Parkinson's Disease Foundation: "Who has
Parkinson's?" Available at:
http://www.pdf.org/parkinson_statistics. Accessed June 21,
2017.
2. Medtronic: MRI guidelines for Medtronic
deep brain stimulation systems. Available at:
http://manuals.medtronic.com/wcm/groups/mdtcom_sg/@emanuals/@era/@neuro/documents/documents/contrib_228155.pdf.
Accessed June 21, 2017.
Contacts:
David T. Young
Public Relations
+1-774-284-2746
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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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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