Medtronic has revealed three-month results from a multicentre randomised controlled trial (RCT) comparing differential target multiplexed (DTM) spinal cord stimulation (SCS) therapy using its Intellis platform with conventional SCS therapy.
Intellis platform is powered by proprietary overdrive battery technology, built to overcome other SCS system limitations.
The trial showed DTM SCS therapy provided better back pain relief compared to conventional SCS.
According to the study, DTM SCS therapy offered at least 50% pain relief in 80% of patients with chronic back pain compared with 51% of patients treated with conventional SCS.
The intensity of pain is typically measured by Visual Analog Scale (VAS).
Medtronic stim and early interventions business vice president and general manager Matt Thomas said: “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 unrivalled simulation platform.”
The study met its principal endpoint of non-inferiority in comparison with conventional SCS and a pre-specified secondary statistical test for superiority indicated a significant difference between DTM and traditional SCS.
The trial will also include a 12-month post-implant patient follow-up.
Earlier this month, Medtronic acquired DTM therapy as part of its acquisition of Stimgenics.
The therapy is available on the Intellis platform and has a unique programming option to treat patients with chronic pain, based on preclinical research.
Recently, Medtronic received CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.