YASTEST
New
Neurostimulation System Is a Non-Opioid Alternative for Chronic
Pain and Offers Personalized Pain Relief and Advanced Activity
Tracking
DUBLIN - November 6, 2017 -
Medtronic plc (NYSE:MDT) today announced that it received CE
(Conformité Européenne) Mark for the
Intellis(TM) platform for both Spinal Cord Stimulation (SCS) and
Peripheral Nerve Stimulation (PNS) as an aid in the management of
certain types of chronic pain.* Intellis, the world's smallest
fully implantable SCS neurostimulator, simplifies and improves the
patient experience with improved battery performance that can power
the EvolveSM workflow,**
which standardizes guidance and balances high-dose (HD) and
low-dose (LD) SCS therapy settings. The Intellis platform is
managed on the Samsung Galaxy Tab S2 tablet interface and can
record and track patient activity 24/7. Intellis is now available
in Europe and the United States.
One in five adults in Western Europe suffers from
chronic pain, a devastating condition with a costly personal and
societal impact.1 Chronic pain
can negatively impact all aspects of a person's life -
relationships, work productivity and activities of daily living,
yet it remains under-recognized and undertreated.1
Published studies have shown that when used by
carefully selected patients with chronic pain, SCS may provide
effective long-term pain relief, improved quality of life and
pain-related disability, and may reduce the need for pain
medications.2 Similarly,
PNS may also provide back pain relief, improvement in back
pain-related disability, and reduce the need for pain
medications.3-4 The
potential benefits of neurostimulation are critical given the
public health issue of prescription pain medication
abuse.5
Earlier intervention with SCS has been shown to
improve treatment outcomes6 and SCS is
widely reimbursed and recommended by European
governments.7-9 Current
European guidelines support the use of SCS; failed back surgery
syndrome is the primary indication recommended by European
governments.10
The first European patient received the Intellis
system at the Pain Clinic of AZ Nikolaas Hospital in Sint-Niklaas,
Belgium where Prof. Jean-Pierre Van Buyten is Chairman and the
procedure was performed by Dr. Iris Smet.
"Chronic pain is a complex disease that is
challenging to manage. The innovations behind the Intellis platform
translate into meaningful patient benefits and ease of use for
physicians, which represent important advantages over other
neurostimulators," said Dr. Iris Smet from AZ Nikolaas. "I want to
restore my patient's health and improve their quality of life; the
innovation behind the Intellis platform allows me to achieve that
and help a broad range of patients."
The Intellis platform can help optimize treatment
and improve patient-physician communication by tracking and sharing
daily activities, body positions and therapy usage and giving
physicians an objective look at mobility and progress.
"Rather than rely on patient-reported data, the enhanced activity
tracker of the Intellis platform provides real-time data that
offers more visibility into quality of life changes," said Prof.
Jean-Pierre Van Buyten of AZ Nikolaas. "Better understanding a
patient's experience can lead to a more informed conversation that
can help me maximize their pain relief and this information is easy
to see and act on with the improved Samsung Galaxy tablet physician
programmer."
"Medtronic's goal is to simplify treatment and
improve the patient experience with personalized therapy that
provides long-term pain relief and helps restore function," said
Marshall Stanton, M.D., senior vice president and president of
Medtronic's Pain Therapies division, which is part of the
Restorative Therapies Group. "The launch of the Intellis platform
is the culmination of 40 years of innovation and what makes
Intellis such an important option is that it integrates
leading-edge hardware with the Evolve workflow for SCS to help
optimize pain relief."
About the Intellis
Platform
The Intellis platform addresses a common patient issue: battery
recharging. With Medtronic's proprietary Overdrive(TM) battery
technology, the Intellis battery can be fully recharged from empty
to full in approximately one hour and physicians can now estimate
recharge intervals based on therapy settings. Secure wireless
Samsung Galaxy Tab S2 programmers for physicians enable faster
delivery of evolving workflows and software upgrades on the
Intellis platform. Intellis also includes both Medtronic's
proprietary SureScan(TM) MRI technology for the broadest access
available to MRI diagnostic imaging and simple eligibility
determination, which allows MRI scans anywhere on the body under
certain conditions for SCS patients, as well as AdaptiveStim(TM)
technology for automatic adjustments to deliver the right therapy
dose to the right location, as the pain target shifts based on body
position.
About Spinal Cord
Stimulation
Medtronic SCS therapy for chronic pain uses a small medical device
called a neurostimulator placed under a patient's skin to deliver
mild electrical impulses through a lead implanted in the epidural
space, which act to block pain signals from going to the brain.
About Peripheral Nerve
Stimulation
In Peripheral Nerve Stimulation, a small medical device called a
neurostimulator sends mild electrical signals directly to the
nerves under the skin near the area of pain, aiming to interrupt or
modify the pain messages before they reach the brain.
About Medtronic Pain
Therapies
Medtronic has the broadest portfolio of pain therapies, which have
been in use for over 40 years and have benefited hundreds of
thousands of patients worldwide. 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, and continues to innovate and bring patient-centric
advances. Medtronic Pain Therapies are reversible, and patients
start with a trial period to judge efficacy.
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 84,000 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:
-
Breivik H, European Journal of Pain 10
287-333 (2006).
-
Taylor RS, Spinal cord stimulation in
Complex Regional Pain Syndrome and Refractory Neuropathic Back and
Leg Pain/Failed Back Surgery Syndrome: results of a systematic
review and meta-analysis. J Pain Symptom Manage. 2006; 31:
S13-S19.
-
Kloimstein H, Likar R, Kern M, et al.
Peripheral Nerve Field Stimulation (PNFS) in Chronic Low Back Pain:
A Prospective Multicenter Study. Neuromodulation.
2013;17(2):180-187.
-
McRoberts WP, Wolkowitz R, Meyer DJ, et
al. Peripheral nerve field stimulation for the management of
localized chronic intractable back pain: results from a randomized
controlled study. Neuromodulation. 2013;16(6):565-575.
-
Shei, Amie, et al., Estimating the
health care burden of prescription opioid abuse in five European
countries. Dove Press 2015:7 Pages 477-488
-
Kumar K., Hunter G., Demeria D et al.,
Spinal cord stimulation in treatment of chronic benign pain:
challenges in treatment planning and present status, a 22-year
experience. Neurosurgery; 58: 481-496 (2006).
-
Nice Recommandation:
http://www.nice.org.uk/guidance/TA159.
-
Haute Autorité de Santé. Evaluation des
systèmes implantables de neurostimulation médullaire. Service
d'évaluation des dispositifs. Saint-Denis La Plaine : HAS ;
2014.
-
AWMF S3 Leitlinie: Epidurale
Rückenmarkstimulation zur Therapie chronischer Schmerzen, Stand
07/2013; Online:
http://www.awmf.org/leitlinien/detail/ll/008-023.html.
-
Cruccu, G., Garcia-Larrea, et al,
EAN guidelines on central neurostimulation therapy in chronic pain
conditions. Eur J Neurol, 23(10):1489-99 (2016).
* The Intellis SCS neurostimulation system is
indicated for SCS as an aid in the management of
chronic, intractable pain of the trunk and/or limbs.
The Intellis PNS neurostimulation system is
indicated for PNS as an aid in the management of
chronic, intractable pain of the posterior trunk.
**A workflow is guidance only and
physicians should use their medical judgement and product labeling
to optimize therapy for individual patients, which may require
discontinuation or modification of a workflow.
Contacts:
Rebecca Fancini
Public Relations
+44-1923-205-149
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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