Medtronic
(NYSE: MDT)
today announced data from two clinical trials supporting its spinal cord stimulation (SCS) technologies.
The medtech giant shared data at the North American Neuromodulation Society (NANS) annual meeting in Las Vegas. Results demonstrated the benefits of SCS in patients with chronic low back pain (CLBP) and leg pain. The company also plans to highlight its recently FDA-approved Percept RC deep brain stimulation system at NANS.
Medtronic’s data included evaluations of closed-loop SCS over three months in Australia. That study looked at the company’s investigational, next-generation rechargeable SCS system. The system holds European and Japanese approval but remains investigational in the U.S. and Australia.
Additionally, Medtronic shared 24-month outcomes for its DTM SCS compared to conventional medical management (CMM).
“Insights gained today from new clinical evidence pave the way toward the revolutionary therapies of tomorrow, and Medtronic is proud to be leading the way at NANS 2024 with 26 accepted clinical abstracts,” said Paolo Di Vincenzo, president of the Neuromodulation business at Medtronic. “We are committed to advancing the field of neuromodulation through rigorous scientific research in order to deliver on our Mission to alleviate pain, restore health and extend life to patients around the world.”
Closed-loop SCS meets primary objective
Medtronic presented one- and three-month outcomes from an evaluation of the long-term performance of its closed-loop SCS system. It also looked at the overall patient experience with the next-generation system.
The study met its primary objective, with 89% (28 people) of subjects reporting a significant reduction in overstimulation relative to open-loop. Additionally, 86% reported a preference for closed-loop therapy during blinded testing at one month. Subjects reported clinically meaningful improvements in pain, physical function and quality of life at three months in closed-loop.
Medtronic also reported that the study met its secondary objective, with 86% (51 subjects) reporting 50% or more reduction in overall back and leg pain at three months. All subjects reported satisfaction with closed-loop SCS therapy at three months.
At three months more than 80% (54) of subjects achieved their stated activity goals for daily living with SCS therapy. This occurred without fear of pain or therapy side effects. The study did not include a weaning protocol but 35% (37) of subjects on opioids at baseline reduced/stopped use at three months. Morphine milligram equivalent reduced from 73.5 to 54.0.
“These early promising results suggest that closed-loop SCS may offer real benefits over fixed-output stimulation,” said Dr. Marc Russo, director of Hunter Pain Specialists in Newcastle, Australia and lead investigator. “Could closed-loop SCS eventually become the standard of care? More data is needed, but what we are seeing thus far is encouraging.”
Medtronic has positive two-year results for DTM SCS
Two-year outcomes comparing DTM SCS waveform to CMM saw superior back pain responder rates for Medtronic’s therapy. Subjects with CLBP reported this at 12, 18 and 24 months.
Medtronic reported a 77% reduction in chronic low back pain at 24 months for patients using DTM SCS. At 24 months, the study saw 93% leg pain responder rates for subjects with more than 50% leg pain relief using DTM SCS.
The study also showed a significant reduction in the extent of disability with DTM SCS as measured by the Oswestry Disability Index (ODI). Medtronic reported a greater than 26-point average ODI reduction at 24 months for those using DTM SCS. Almost all patients (95%) labeled themselves as “satisfied” or “very satisfied” with DTM SCS at two years.
Medtronic says that results showed the advantages of DTM SCS in pain reduction compared to CMM.
“As the first DTM SCS RCT in Europe, these results provide additional evidence of the clinical and quality-of-life benefits that DTM™ SCS offers this patient population, which has few available treatment options,” said Dr. Jan Willem Kallewaard, anesthesiologist at Rijnstate, Elst, The Netherlands, and the study’s lead investigator.