DTM™ Spinal Cord Stimulation Using the Medtronic Intellis™ Platform Shows Superior Back Pain Relief Compared to Conventio...
January 21 2020 - 5:07PM
Medtronic plc (NYSE:MDT) today announced three-month results
from a large, multicenter randomized controlled trial (RCT) showing
statistically significant (p=0.0009) and superior back pain relief
with Differential Target Multiplexed (DTM™) Spinal Cord Stimulation
(SCS) compared to conventional SCS. Both arms used the Medtronic
Intellis™ platform. Three-month results showed 80% of patients with
chronic back pain treated with DTM reported at least 50% pain
relief, compared with 51% of patients treated with conventional
SCS, as measured by the Visual Analog Scale (VAS), a widely used
and accepted measure for pain intensity.1 Fifty-percent pain
relief, as measured by VAS, is a recognized industry standard to
define minimum therapy success.
The RCT demonstrated profound pain relief and
significant reductions in back and leg pain with DTM. Sixty-three
percent patients with back pain treated with DTM reported profound
pain relief of 80% or greater compared to 26% treated with
conventional SCS. In aggregate, patients treated with DTM reported
an average of 74% reduction in back pain compared to 46% with
conventional SCS at three months.1 Similarly,
improvements were observed with DTM for leg pain with a
mean reduction of 72% compared to 59% with conventional SCS.1
The RCT results reported are from 94 implanted SCS
patients who were randomized to either the treatment or control arm
and followed over the course of three months. With these results
the study met its primary endpoint of noninferiority compared with
conventional SCS, and a pre-specified secondary statistical test
for superiority showing the difference between DTM and conventional
SCS as highly significant. The study will continue to follow
patients through 12 months post implant.
Medtronic acquired DTM therapy as part of its
acquisition of Stimgenics announced in early January. DTM
therapy, which was proven through the RCT only on the Medtronic
Intellis platform, is a new and unique programming option available
to treat patients with chronic pain that is based on years of
preclinical research.3,7
“DTM therapy is the first tailored SCS approach
intentionally developed from a novel scientific concept and
demonstrated in an RCT. The study demonstrates that DTM therapy
provides superior efficacy for patients with chronic back pain
compared to conventional stimulation,” said Matt Thomas, vice
president and general manager of the Stim and Early Interventions
business, which is part of the Restorative Therapies Group at
Medtronic. “Combined with Intellis, patients can access superior
outcomes as demonstrated in the RCT on an unrivaled stimulation
platform.”
The DTM waveform may engage a novel mechanism that
modulates both neurons and glial cells, expanding the understanding
of SCS mechanisms of action. Glial cells outnumber neurons in the
spinal cord by 12:1 and their role in pain have been explored in
research for more than 20 years.2-4
DTM has been studied in animal models, showing
statistically significant reversal of pain behaviors compared to
either low frequency or high frequency alone.6,7 In addition,
preclinical studies investigating the genome of nerve-injured
animals suggests that the DTM waveform has a greater impact in the
neural-glial interaction than other frequencies. Basic science
research is further expanding our understanding of SCS mechanisms
of action. Glial cells are no longer thought to be only “glue”
in the brain and spinal cord but active contributors to
neural processing and various disease states including chronic
pain.8
Results from the RCT are
being presented at the North American Neuromodulation
Society (NANS) annual meeting Jan. 23-26, 2020 in Las Vegas and can
also be found on the Medtronic website.
Analyst and Investor
BriefingMedtronic will host a webcast on Friday, Jan. 24,
2020 from 8:30 a.m. to 9:30 a.m. Pacific Standard Time from the
NANS annual meeting in Las Vegas. The webcast will feature remarks
from the Medtronic Restorative Therapies Group management team. The
live audio webcast can be accessed by clicking on the Investor
Events link on the Medtronic Investor Relations
website on Jan. 24. Within 24 hours of the webcast, a replay
will be available on the same page. This event is not part of the
official NANS 2020 program.
About the
IntellisTM PlatformThe Intellis platform offers the
world’s smallest implantable neurostimulator. It is powered by
proprietary Overdrive™ battery technology and was designed to
overcome limitations with other SCS systems, optimized for a wide
range of energy demands and provides effective long-term pain
relief for patients. The neurostimulator also features SureScan™
MRI, allowing access to MRI anywhere in the body under certain
conditions, and AdaptiveStim™ technology, which automatically
adjusts stimulation based on the patient’s needs and preferences in
different body positions to ensure the patient receives the right
dose of stimulation at the right location.
About Medtronic Pain
TherapiesMedtronic has more than a 40-year history of
developing innovative medical devices that have been shown to
alleviate pain in different disease states and has a broad
portfolio of device-delivered therapies that are alternatives or
adjuncts to oral opioids.9 Medtronic strives to be at the
forefront of medical device innovation and to develop high-quality
pain therapies that reduce pain and improve quality of life. While
Medtronic pain therapies do not treat opioid addiction, we are
committed to leveraging our capabilities and product portfolio in
partnership with stakeholders — patients, providers, payers,
regulators, elected officials, patient advocacy groups and
employers — to address the unmet needs of pain patients and to
support efforts to prevent opioid misuse due to chronic intractable
pain.
About MedtronicMedtronic 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 90,000 people worldwide, serving physicians, hospitals and
patients in more than 150 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
- Fishman M, Cordner H,
Justiz R et al. Randomized Controlled Clinical Trial to Study
the Effects of DTM-SCS in Treating Intractable Chronic Low Back
Pain: 3 Month Results. Presentation at NANS 2020, Las Vegas,
Nevada.
- Milligan ED, Watkins LR. Pathological and protective
roles of glia in chronic pain. Nat Rev Neurosci. 2009
Jan;10(1):23-36.
- Vallejo R, Tilley DM, Vogel L, Benyamin R. The role of glia and
the immune system in the development and maintenance of neuropathic
pain. Pain Pract. 2010 May-Jun;10(3):167-84.
- De Leo JA, Tawfik VL, LaCroix-Fralish ML. The tetrapartite
synapse: Path to CNS centralization and chronic pain. Pain. 2006;
122:17-21.
- Ruiz-Sauri A.,
Orduña-Valls J.M., Blasco-Serra A. et al. Glia to neuron ratio in
the posterior aspect of the human spinal cord at thoracic segments
relevant to spinal cord stimulation. Journal of Anatomy, vol.
235, no. 5, 2019, pp. 997-1006.
- Cedeno D.L., Cass C.L., Kelley C.A., et al.
Pre-clinical comparison of differential-target multiplexed scstm
with low and high rate SCS. Neuromodulation 2019 22:3 (E185-)
- Cedeno D.L., Kelley C.A., Cass C.L., et al. Pre-clinical
Comparison of Differential-Target Multiplexed SCS with Low and High
Rate SCS. Presentation at ASRA 2018. San Antonio, Texas.
- Allen NJ, Barres BA.
Neuroscience: Glia - more than just brain glue. Nature. 2009 Feb
5;457(7230):675-7.
- Deer T. Atlas of implantable therapies for pain
management. New York, NY: Springer Science and Business Media,
LLC; 2011.
Michelle ClaypoolPublic Relations+1-763-526-9452
Ryan WeispfenningInvestor Relations+1-763-505-4626
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