DUBLIN, Oct. 20, 2020 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced statistically significant 12-month results from a large,
multicenter randomized controlled trial (RCT) that further validate
the superiority of DTM™ Spinal Cord Stimulation (SCS) in providing
back pain relief, compared with conventional SCS therapy, using the
Medtronic Intellis™ platform.
At 12 months, 84% of patients with chronic back pain treated
with DTM SCS reported at least 50% pain relief, compared to 51% of
patients treated with conventional SCS (p=0.0005).1
There was also a difference in the proportion of patients who
reported profound back pain relief (>80% reduction in VAS score)
favoring DTM SCS (69%) compared with conventional SCS
(35.1%).1 The study met its primary endpoint at three
months, and in pre-specified secondary analysis showed the
superiority of DTM SCS compared to conventional SCS and has
sustained these results at 12 months.
Pain relief was measured by the Visual Analog Scale (VAS), a
widely used and accepted measure for pain intensity that records
patient-reported pain levels on a scale of 0-10. Fifty-percent pain
relief, as measured by VAS, is a recognized industry standard to
define therapy success. The majority of DTM SCS patients in this
study exceeded this threshold, with seven out of ten experiencing
profound back pain relief at 12 months.
Patients treated with DTM SCS also reported an average VAS score
reduction of 75% in back pain, compared with 50% treated with
conventional SCS. Average VAS scores for patients treated with DTM
SCS at 12 months were 1.74 for back pain and 1.45 for leg
pain.1 The term remitter has previously been used to
classify patients with a pain score of 2.5 or less. As a group,
patients in the DTM SCS group clearly fell below this level with a
mean VAS score of 1.74 for back pain and 1.4 for leg pain.
"DTM SCS has the potential to improve outcomes for patients with
chronic back pain," said Michael
Fishman, M.D., MBA, anesthesiologist and Interventional Pain
Medicine specialist at the Center for Interventional Pain &
Spine. "More than two-thirds of the patients in this RCT achieved
profound pain relief of at least 80% with DTM SCS therapy. These
outcomes demonstrate that DTM SCS can provide more patients
profound pain relief compared with conventional SCS at 12 months,
which physicians should consider when selecting a neuromodulation
therapy for their patients."
"DTM SCS is based on a novel understanding of how neurons and
glial cells contribute to chronic pain," said Charlie Covert, vice president and general
manager of the Pain Therapies business, part of the Restorative
Therapies Group at Medtronic. "The 12-month data reported
demonstrate the value of Medtronic's continued focus on pursuing
science-based approaches to improving human health and underscore
our ability to integrate existing technologies with novel therapies
like DTM SCS to improve the outcomes of people suffering from
chronic pain."
Go to Medtronic.com/DTMwebinar to register for a webinar on
Tues. Oct. 20 at 12 p.m. CDT to learn more about the clinical
trial results.
About the Trial
The data reported are from
an RCT in which SCS patients were randomized to either
the treatment or control arm, with 79 subjects implanted and
followed over the course of 12 months. The study previously met its
primary endpoint of noninferiority compared with conventional SCS
at three months, and a prespecified secondary statistical test for
superiority showing the difference between DTM SCS and conventional
SCS as highly significant. Medtronic previously reported
three-month data from the trial in January
2020.
About DTM SCS Therapy
DTM SCS therapy is a new and
proprietary spinal cord stimulation algorithm available to treat
patients with chronic pain. It is delivered as a programming option
via the Medtronic Intellis SCS platform. It is inspired by science
and rooted in preclinical work prior to being proven in an RCT. 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 has been explored in research
for more than 20 years.2-4
About the Intellis SCS Platform
The Intellis SCS
platform, indicated to aid in the management of chronic,
intractable pain, 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 technology, 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
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 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.
References
- Fishman M, Cordner H, et al. DTM™ SCS RCT 12-month Data
Results. Presented at a Medtronic webinar, jointly supported by the
North American Neuromodulation Society (NANS), World Institute of
Pain(WIP), and the American Society for Pain and Neuroscience
(ASPN). October 19, 2020. Webinar
available on society websites.
- 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.
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SOURCE Medtronic plc