Medtronic Enrolls First Patient In Pain Study to Assess Optimized Spinal Cord Stimulation Programming
January 09 2018 - 7:00AM
YASTEST
As More Physicians
Seek Non-Opioid Treatment Options, the Vectors Study Will Further
Advance Understanding of New Approaches to Optimal Spinal Cord
Stimulation Treatment
DUBLIN - January 9, 2018 -
Medtronic plc (NYSE:MDT) today announced the first patient enrolled
in the Vectors Post Market Clinical Study. The study will follow
patients with chronic intractable pain who are undergoing spinal
cord stimulation (SCS) treatment managed with the EvolveSM
workflow*, which
standardizes guidance that balances high-dose (HD) and low-dose
(LD) therapy settings to help physicians optimize treatment. Evolve
runs on Medtronic SCS systems including Intellis(TM), the world's
smallest implantable SCS neurostimulator, which recently received
U.S. Food and Drug Administration and CE Mark approval. The first
patient was enrolled by The Center for Interventional Pain &
Spine in Wilmington, Delaware.
"Our goal is to improve or restore function. Even
with all of today's technological advances, chronic pain can be
challenging to manage; this is further complicated by the opioid
crisis," said Michael Fishman, M.D., from The Center for
Interventional Pain & Spine. "Standard treatment guidance has
the potential to help optimize pain relief, and the Vectors Post
Market study will provide valuable data about the efficacy of high
dose stimulation using standardized programming through the Evolve
workflow."
The Vectors study is a prospective, multi-center,
post-marketing study that will enroll up to 175 patients with
chronic intractable pain of the low back and legs at up to 25 sites
in the U.S. The study will assess SCS's long-term efficacy and
impact on quality of life and was designed to provide evidence for
the Evolve workflow by evaluating the effectiveness and potential
patient benefits of having access to both HD and LD stimulation
modalities. Patients will be followed for 12 months post
implant.
"The Vectors study will generate meaningful data
about the use of the Evolve workflow and will help further
physicians' understanding of how to use this simple, versatile
approach to enable effective, long-term pain relief with SCS," said
John Hathaway, M.D., Northwest Pain Care of Spokane, Washington and
primary investigator. "Knowing how to best use non-opioid treatment
options - like the Intellis SCS platform - is more important than
ever, and this data may help us expand our ability to help people
struggling with chronic intractable pain."
The Intellis platform offers important patient
benefits. Using Medtronic's proprietary Overdrive(TM) battery
technology, the Intellis platform can be fully recharged in
approximately one hour, addressing a common patient complaint about
the burden of recharging their implant. Physicians also get new
tools, including Snapshot(TM), a software platform that tracks
activity, body positions and therapy usage. This empowers
physicians with objective insights about patient outcomes, like
mobility and progress.
"Medtronic is committed to advancing the treatment
of people with intractable chronic pain. To maximize our impact,
our goal is to expand the clinical understanding of optimal
approaches to SCS treatment," said Marshall Stanton, M.D., senior
vice president and president of Medtronic's Pain Therapies
division, which is part of the Restorative Therapies Group.
"Building on our 40-year legacy, the Vectors study will provide
important evidence about how to best leverage both high dose and
low dose stimulation with the Evolve workflow, which was designed
to simplify patient management and standardize therapy for the best
possible outcome. It's not just about pain relief, but about return
to function."
About Chronic Pain
At least 100 million American adults - more than the combined total
affected by heart disease, cancer, and diabetes - are affected by
chronic 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.2
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.3-7
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.3-5,
8
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, including new minimally invasive spine surgical
technologies.
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:
-
Relieving Pain in America: A Blueprint for
Transforming Prevention, Care, Education, and Research; Consensus
Report, Institute of Medicine (IOM), The National Academies Press,
June 2011.
-
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
-
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).
-
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).
-
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).
-
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).
-
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).
-
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.
* A workflow is guidance only and physicians
should use their medical judgment and product labeling to optimize
therapy for individual patients, which may require discontinuation
or modification of a workflow.
Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098
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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