Medtronic (NYSE: MDT) announced today that FDA has approved revised commercial labeling that touts superior back pain relief for its Intellis spinal cord stimulation platform.
Intellis uses differential target multiplexed (DTM) programming, which Medtronic describes as a unique and proprietary programming option based on years of preclinical research. Recent study outcomes from a multicenter randomized control trial found DTM SCS produced improved results over conventional SCS, according to Medtronic.
At 3 months, 81% of patients treated with DTM SCS reported their back pain was at least halved, compared with 51% of patients treated with conventional SCS. The study used the Visual Analog Scale (VAS), a widely used and accepted measure for pain intensity.
The new labeling update follows the most recent 12-month clinical trial outcomes, reported during a late-breaking clinical trial session at NANS 2021. The trial found 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.
“The body of clinical evidence proving the efficacy of DTM SCS in treating patients with chronic back pain continues to grow,” said Charlie Covert, VP and general manager of Pain Therapies within Medtronic’s neuromodulation business. “The updated labeling further strengthens the credibility of the outcomes from this therapy,