Charles Sternberg, Assistant Editor03.17.21
The U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for Medtronic plc’s Intellis Platform with Differential Target Multiplexed (DTM) programming for the treatment of chronic, intractable back and leg pain. The new labeling will include study outcomes from a multicenter randomized control trial reflecting superior back pain relief with DTM SCS when compared to conventional SCS.
Clinical Trials
The trial demonstrated with clinical and statistical significance that DTM SCS programming is superior to conventional SCS programming when used to treat intractable chronic back pain. At three months, 80% of patients treated with DTM SCS reported back pain relief of at least 50%, 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
This labeling update closely follows the most recent presentation of 12-month clinical trial outcomes during a late-breaking clinical trial session at NANS 2021.2 Trial results showed statistically significant and superior back pain relief with DTM SCS compared to conventional SCS 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. 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%).2
"The body of clinical evidence proving the efficacy of DTM SCS in treating patients with chronic back pain continues to grow," said Charlie Covert, vice president and general manager, Pain Therapies within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "The updated labeling further strengthens the credibility of the outcomes from this therapy, and parallels the profound benefits our clinician partners are seeing with their own patients."
DTM therapy, which is clinically proven and only available on the Medtronic Intellis platform, is a unique and proprietary programming option available to treat patients with chronic pain that is based on years of preclinical research.3,4,5
Clinical trial data can be found here. A manuscript has been submitted for consideration for peer-reviewed publication.
References:
1. Fishman M, Cordner H, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of SGX-SCS in Treating Intractable Chronic Low Back Pain: 3 Month Results. North American Neuromodulation Society (NANS); 2020; Las Vegas, Nevada.
2. Fishman M, Cordner H, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of Differential Target Multiplexed™ SCS (DTMTM SCS) in Treating Intractable Chronic Low Back Pain: Long-term Follow-Up Results. Presented at: North American Neuromodulation Society 24th Annual Meeting. Jan 15-16, 2021. Virtual.
3. Vallejo R, Kelley CA, Gupta A, Smith WJ, Vallejo A, Cedeño DL. Modulation of neuroglial interactions using differential target multiplexed spinal cord stimulation in an animal model of neuropathic pain. Mol Pain. 2020 Jan-Dec;16:1744806920918057.http://dx.doi.org/10.1177/1744806920918057
4. 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.
5. Cedeno DL, Smith WJ, Kelley CA, Vallejo R. Spinal cord stimulation using differential target multiplexed programming modulates neural cell-specific transcriptomes in an animal model of neuropathic pain. Mol Pain. 2020;16:1744806920964360. http://dx.doi.org/10.1177/1744806920964360
Clinical Trials
The trial demonstrated with clinical and statistical significance that DTM SCS programming is superior to conventional SCS programming when used to treat intractable chronic back pain. At three months, 80% of patients treated with DTM SCS reported back pain relief of at least 50%, 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
This labeling update closely follows the most recent presentation of 12-month clinical trial outcomes during a late-breaking clinical trial session at NANS 2021.2 Trial results showed statistically significant and superior back pain relief with DTM SCS compared to conventional SCS 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. 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%).2
"The body of clinical evidence proving the efficacy of DTM SCS in treating patients with chronic back pain continues to grow," said Charlie Covert, vice president and general manager, Pain Therapies within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "The updated labeling further strengthens the credibility of the outcomes from this therapy, and parallels the profound benefits our clinician partners are seeing with their own patients."
DTM therapy, which is clinically proven and only available on the Medtronic Intellis platform, is a unique and proprietary programming option available to treat patients with chronic pain that is based on years of preclinical research.3,4,5
Clinical trial data can be found here. A manuscript has been submitted for consideration for peer-reviewed publication.
References:
1. Fishman M, Cordner H, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of SGX-SCS in Treating Intractable Chronic Low Back Pain: 3 Month Results. North American Neuromodulation Society (NANS); 2020; Las Vegas, Nevada.
2. Fishman M, Cordner H, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of Differential Target Multiplexed™ SCS (DTMTM SCS) in Treating Intractable Chronic Low Back Pain: Long-term Follow-Up Results. Presented at: North American Neuromodulation Society 24th Annual Meeting. Jan 15-16, 2021. Virtual.
3. Vallejo R, Kelley CA, Gupta A, Smith WJ, Vallejo A, Cedeño DL. Modulation of neuroglial interactions using differential target multiplexed spinal cord stimulation in an animal model of neuropathic pain. Mol Pain. 2020 Jan-Dec;16:1744806920918057.http://dx.doi.org/10.1177/1744806920918057
4. 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.
5. Cedeno DL, Smith WJ, Kelley CA, Vallejo R. Spinal cord stimulation using differential target multiplexed programming modulates neural cell-specific transcriptomes in an animal model of neuropathic pain. Mol Pain. 2020;16:1744806920964360. http://dx.doi.org/10.1177/1744806920964360