Medtronic Receives CE Mark for the World's Smallest Fully Implantable Spinal Cord Stimulator and Announces European Launch of the Intellis Platform
(Thomson Reuters ONE) -
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
Evolve(SM) 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 outcomes(6)
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:
1. Breivik H, European Journal of Pain 10 287-333 (2006).
2. 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.
3. 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.
4. 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.
5. Shei, Amie, et al., Estimating the health care burden of prescription
opioid abuse in five European countries. Dove Press 2015:7 Pages 477-488
6. 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).
7. Nice Recommandation: http://www.nice.org.uk/guidance/TA159.
8. Haute Autorité de Santé. Evaluation des systèmes implantables de
neurostimulation médullaire. Service d'évaluation des dispositifs. Saint-
Denis La Plaine : HAS ; 2014.
9. AWMF S3 Leitlinie: Epidurale Rückenmarkstimulation zur Therapie chronischer
Schmerzen, Stand 07/2013; Online:
http://www.awmf.org/leitlinien/detail/ll/008-023.html.
10. 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
Unternehmensinformation / Kurzprofil:
Datum: 06.11.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 566664
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contact information:
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