Medtronic has announced that the US Food and Drug Administration (FDA) has approved the revised commercial labelling for the Intellis platform with differential target multiplexed (DTM) programming. This is to reflect the outcomes of a randomised controlled trial which, according to a company press release, shows superior back pain relief with DTM spinal cord stimulation (SCS) when compared with conventional SCS.
According to Medtronic, 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. The company reports that st 3 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.
This labelling update closely follows the most recent presentation of 12-month clinical trial outcomes during a late-breaking clinical trial session at NANS 2021, the company reports. 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, claims Medtronic.
The company press release further reports there was also a difference in the proportion of patients who reported profound back pain relief (>80% reduction in VAS score) favouring DTM SCS (69%) compared with conventional SCS (35.1%).
“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.”