Medtronic Releases 12-Month Clinical Data on the Inceptive CL-SCS

Medtronic announced 12-month data on the clinical trial (NCT05177354) of its Inceptiv closed-loop spinal cord stimulator (CL-SCS) in patients with chronic Low-back pain (CLBP) and leg pain. The data will be presented at the North American Neuromodulation Society (NANS) 2025 meeting. 

The Inceptiv spinal cord stimulator senses† biological signals along the spinal cord, and automatically adjusts stimulation in real-time. The device received its FDA approval in April 2024.

The objective of the prospective, multi-center, single-arm study, “Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop SCS System,” was to characterize the efficacy of the Inceptiv SCS system for treating chronic neuropathic pain and improving quality of life. Patients were randomized with closed loop on/off periods.

“These results add to the growing body of high-quality evidence demonstrating the long-term efficacy of SCS in reducing pain and improving quality of life, said Dr. Ashwini Sharan, chief medical officer of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. “We are especially pleased that so many patients in this study not only found pain relief with Inceptiv SCS, but were also comfortable letting the closed-loop feature make stimulation adjustments automatically, lessening the burden of manual therapy changes. The reduced need for manual adjustments, combined with positive therapy experience and satisfaction, may lead to better therapy compliance and durability of outcomes.”

Key findings from the study include:

• 93% of patients reported a reduction in overstimulation with the CL feature during in-clinic testing (n=43)
• 88% of patients preferred having the CL feature On (vs. Off; n = 43)
• At-home experience was consistent with the in-clinic testing results – 91% of participants (n = 46) reported not experiencing uncomfortable stimulation during activities of daily living
• 82% reported 50% or more reduction in low-back pain intensity with a mean reduction of 67% (n = 38)
• 50% were able to reduce or stop the use of opioid medications (n=32 with MME>0 at baseline)
• 87% of subjects (n = 46) improved in 3 or more domains of a composite endpoint that includes pain (VAS reduction ≥30%), QoL (EQ-5D-5L increase ≥0.074), physical function (Oswestry Disability Index reduction≥10), mood (POMS reduction ≥10) and sleep quality (PSQI reduction ≥3.0)
• With the closed-loop feature on, patients made only 1 median adjustment to programming every 30 days. By comparison, in a U.S. SCS patient market research survey across multiple manufacturers, 50% of participants (n = 100) made frequent adjustments at least a few times per week.¹
• 100% of subjects (n = 46) expressed satisfaction with CL-SCS therapy and 98% would recommend to friends and family

“The 12-month data demonstrate that Inceptiv with closed-loop technology provides significant benefits in improving pain, quality of life and physical function scores while substantially reducing overstimulation,” said Dr. Vahid Mohabbati, MD, director of the Sydney Pain Research Centre in Sydney, Australia and an investigator on the trial. “The findings that 50% of patients were able to decrease or discontinue opioid pain medication and the median number of times that patients adjusted their stimulation amplitude was only once every 30 days underscore that Inceptiv with closed-loop sensing can reduce treatment burden while providing effective pain relief. These results emphasize the importance of tailoring stimulation and ensuring consistency of dosing for optimal benefits from SCS therapy as patients engage in activities of daily living.”  

The primary and secondary study endpoints were previously met and presented. The primary endpoint was at least a 50% reduction in overstimulation with the CL feature On vs. Off at 1 month. The secondary endpoint was the proportion of patients with at least a 50% reduction in overall, back, leg, or upper limb (UL) VAS scores at 3 months (88% low-back and 77% leg, 100% UL). Study subjects will have 18- and 24-month follow-ups.