YASTEST
The Intellis
Platform Includes the World's Smallest Implantable Spinal Cord
Stimulator and
Offers Personalized Pain Relief and Advanced
Activity Tracking
DUBLIN - September 18, 2017 -
Medtronic plc (NYSE:MDT) today announced FDA approval and U.S.
launch of the Intellis(TM) platform for the management of certain
types of chronic intractable pain. The Intellis platform was
designed to overcome limitations with current spinal cord
stimulation (SCS) systems, such as battery performance, and can
power the EvolveSM
workflow*, which
standardizes guidance and balances high-dose (HD) and low-dose (LD)
therapy settings. The Intellis platform can record and track
patient activity 24/7 and is managed on the Samsung Galaxy Tab S2
tablet interface, enabling physicians to address the subjective and
personal nature of chronic pain by monitoring progress and making
modifications to better suit their patients' therapy needs.
Duke University Medical Center in Durham, N.C.
implanted one of the first patients in the U.S. with the Intellis
device.
"Chronic pain is challenging to manage. Having
real-time data can provide more information about patients' quality
of life changes," said Dr. Lance Roy, pain medicine specialist at
Duke University Medical Center. "This platform represents a welcome
new option for managing some kinds of chronic pain. New non-opioid
treatment options are important given the national crisis related
to opioid abuse."
Back problems are one of the top 10 most expensive
medical conditions, with an estimated 30 percent of the 300,000
patients annually that undergo lumbosacral spine procedures
developing chronic intractable pain.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
Neurostimulation has been proven to provide effective long-term
pain relief and improve quality of life, in addition to being a
treatment option for patients interested in trying a non-drug
alternative.2-6
"Drawing upon our 40-year legacy in SCS, the
launch of the Intellis platform isn't just about a new device, but
about combining cutting edge hardware with optimal therapy through
the Evolve workflow to enable personalized, long-term pain relief,"
said Marshall Stanton, M.D., senior vice president and president of
Medtronic's Pain Therapies division, which is part of the
Restorative Therapies Group. "Medtronic is committed to addressing
patient needs, so the Intellis platform was designed based on what
is most important to patients and physicians. We considered the
entire patient journey - starting with the primary goal of optimal
pain relief and access to important diagnostic tools, like MRI, to
ease of use with simplified programming, faster recharge and a
smaller implant."
About the Intellis(TM)
Platform
The Intellis platform can help optimize treatment and improve
patient-physician communication by tracking and sharing daily
activities, body positions and therapy usage and by giving
physicians an objective look at mobility and progress. The Intellis
platform also addresses a common patient complaint: battery
recharge issues. 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.
Additional advances in the Intellis platform
include secure wireless Samsung Galaxy Tab S2 programmers for
physicians that enable faster delivery of evolving workflows and
software upgrades. The Intellis implantable neurostimulator was
designed for improved patient comfort and is the world's smallest
fully implantable SCS neurostimulator. The Intellis platform 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, 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.
"We are excited to partner with Medtronic in their
aim to simplify programming, and streamline therapy management with
the Intellis platform," said Dr. Dave Rhew, chief medical officer
and head of Healthcare and Fitness for Samsung Electronics America.
"Samsung's Galaxy tablets-secured by the HIPAA-ready Samsung Knox
mobile security platform-will support future Medtronic therapies
and over the air (OTA) software upgrades to ensure clinicians using
Intellis have access to the most up-to-date solutions."
About Spinal Cord
Stimulation
Medtronic neurostimulation therapy for chronic intractable pain
uses a medical device placed under a patient's skin to deliver mild
electrical impulses through a lead implanted in the epidural space
to block pain signals from going to the brain. SCS is a non-opioid
therapy that is clinically proven and cost-effective for treating
chronic pain. Multiple randomized controlled trials have
demonstrated that SCS provides more effective pain relief than both
re-operation and conventional medical management.2-4,
7
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Medtonic's Intellis(TM) Spinal Cord Stimulation
Platform |
Click the thumbnail above for a larger image.
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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.
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.
All other brands, product names, company names,
trademarks and service marks are the properties of their respective
owners. All rights reserved.
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-
*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.
References:
1. Mekhail N, Wentzel DL, Freeman R, Quadri H. Counting
the costs: case management implications of spinal cord stimulation
treatment for failed back surgery syndrome. Prof Case Manag.
2011;16(1):27-36.
2. North RB., Kidd DH., Farrokhi F, et al. Spinal cord
stimulation versus repeated lumbosacral spine surgery for chronic
pain: a randomized, controlled trial. Neurosurg; 56: 98-106
(2005).
3. Kumar K., Taylor RS., Jacques L, et al., Spinal cord
stimulation versus conventional medical management for neuropathic
pain: a multicenter randomised controlled trial in patients with
failed back surgery syndrome. Pain; 132: 179-188. (2007).
4. Kemler MA., De Vet HCW., Barendse GAM et al., The
effect of spinal cord stimulation in patients with chronic reflex
sympathetic dystrophy: two years' follow-up of the randomized
controlled trial. Ann Neurol; 55: 13-18 (2004).
5. 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; 31: S13-S19
(2006).
6. Cameron T, Safety and efficacy of spinal cord
stimulation for the treatment of chronic pain - a 20 year
literature review. J Neurosurg Spine; 100: 254-267
(2004).
7. Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M,
Molet J, et al. The effects of spinal cord stimulation in
neuropathic pain are sustained: a 24-month follow-up of the
prospective randomized controlled multicenter trial of the
effectiveness of spinal cord stimulation. Neurosurgery.
2008;63(4):762-70.
Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098
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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