Medtronic recently announced the three-month results from a large, multicenter randomized controlled trial (RT) showing statistically significant and superior back pain relief through Differential Target Multiplexed (DTM™) Spinal Cord Stimulation (SCS) compared to conventional SCS. Both therapies were evaluated using the Intellis™ neurostimulator.
The trials began on the hypothesis of: Do glial and neuronal cells have varied responses to different waveforms?
The Trial Result Discussion
The DTM™ waveform engages a novel mechanism that modulates both neurons and glial cells, expanding the understanding of SCS mechanisms of action. Glial cells are supportive cells in the central nervous system. Unlike neurons, glial cells do not conduct electrical impulses and they outnumber neurons in the spinal cord by 12:1.
Prior research has shown that glial cells are active contributors to chronic pain. Glial cells are activated when there is trauma that is released as an inflammatory state to act as a cure. The transition from acute to chronic pain occurs when the neuro-glial cells are not reverted back to the anti-inflammatory stage. DTM™ SCS impacts the neuronal-glial interactions by reverting them to non-inflammatory.
From the Medtronic press release: Three-month results showed 80% of patients with chronic back pain treated with DTM reported 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.
DTM™ Spinal Cord Stimulation Application
The DTM™ SCS algorithm includes three therapy options, four signals, six anatomical targets, and six patient amplitudes. It begins by programming Medtronic’s Intelius neurostimulators.
Patients eligible for DTM have significant back pain and moderate to severe leg pain who are also naïve to SCS treatment.
“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, Combined with Intellis, patients can access superior outcomes as demonstrated in the RCT on an unrivaled simulation platform.”
– 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.
Medtronic’s Competitive Market Share Analysis
In 2020, Medtronic led the total neuromodulation device market. As Medtronic was the first company to release an SCS product, Interstim™, it has brand recognition, a strong reputation, and established relationships with physicians. SNS therapy was FDA approved in 1997 and, to date, more than 300,000 people have received Interstim™ therapy worldwide.
The company still has the vast majority of the market share, since competition in the U.S. market is relatively new; Abbott and Boston Scientific now offer devices in this space but have yet to take a significant market share from Medtronic.
Spinal Cord Stimulation Market Size and Forecast
In 2019, almost 70,000 spinal cord stimulation procedures were performed in the US. The Spinal Cord Stimulation Market size is currently valued at over 1.8 billion. Currently, the biggest market driver is the low market penetration.
Register to receive a free US Market Report Suite for Neuromodulation Market 2020-2026 synopsis
Although SCS devices were developed in the early 1970s, the U.S. market is not saturated. The low penetration rate indicates that the market has growth potential, allowing the number of units sold to continue growing without slowing significantly over time.