Dive Brief:

• Medtronic has shared more clinical data on its closed-loop spinal cord stimulation (SCS) system, called Inceptiv, linking the device to sustained improvements across 12 months of treatment.
• The results, which Medtronic published Thursday, show 93% of patients reported a reduction in overstimulation with the closed-loop technology during in-clinic testing and 88% of people preferred having the feature turned on.
• Medtronic won approval for the Inceptiv device in the U.S. in April. The data update, which adds to results shared last year, gives Medtronic more evidence to cite as it tries to increase sales of a product that drove double-digit growth at the company’s pain stimulation unit in the last quarter.

Dive Insight:

Inceptiv is the first closed-loop SCS system launched in the U.S. by one of the big four pain stimulation players. Older devices from Medtronic, as well as products from its main rivals Abbott, Boston Scientific and Nevro, are all open-loop systems. Open-loop devices provide a set amount of stimulation. Inceptiv, in contrast, adapts the amount of stimulation it delivers based on signals from the body. 

The adjustment is intended to prevent overstimulation, which can be uncomfortable and drive users to choose a lower, less effective level of stimulation. Medtronic previously showed 89% of people reported a significant reduction in overstimulation relative to open loop, achieving the trial’s primary endpoint.

At the North American Neuromodulation Society 2025 meeting next week, Medtronic will present 12-month data from the trial. The update shows the benefits persisted after one month. After 12 months, 91% of patients reported not experiencing uncomfortable stimulation during activities of daily living. More than four-fifths of people said their low-back pain improved by 50% or more.

Half of the patients reduced or stopped their use of opioid pain drugs. Patients made a median of one adjustment to programming every 30 days with the closed-loop feature turned on. Medtronic compared the result to a survey that found half of users of open-loop systems adjusted the programming at least a few times a week.

Medtronic has reported double-digit growth year over year in pain stim sales in both quarters since launching Inceptiv in the U.S., achieving increases of 11% and 10% in August and November, respectively. Medtronic did not report pain stim sales in the quarter before the launch. Neuromodulation, the business that houses the pain stim unit, went from mid-single digit growth year over year pre-Inceptiv to nearly 13% growth in Medtronic’s fiscal second quarter, which ended in late October.

Evercore ISI analysts predicted Inceptiv would revitalize Medtronic’s SCS business. When the company won Food and Drug Administration approval in April, the analysts said Medtronic appeared to have been losing market share to Abbott for the previous year. The analysts said Inceptiv could help Medtronic take back market share.