The clinical trial evaluated Inceptiv in patients with chronic low-back pain (CLBP) and leg pain. Medtronic plans to present data at the North American Neuromodulation Society (NANS) 2025 meeting next week in Orlando.
Inceptiv treats chronic pain and represents Medtronic’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the motions of daily life.
The medtech giant also labeled it the world’s smallest and thinnest fully implantable SCS device. Medtronic won FDA approval for Inceptiv in April 2024.
Medtronic said its study aims to characterize the efficacy of the Inceptiv SCS system for treating chronic neuropathic pain and improving quality of life. Investigators randomized patients with closed-loop on/off periods.
“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, 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.”
A look at the data from Medtronic
Findings included 93% of patients (43 subjects) reporting a reduction in overstimulation with the CL feature during in-clinic testing. Additionally, 88% preferred having the CL feature on as opposed to off. The at-home experience fell in line with in-clinic testing results with 91% (46) reporting no uncomfortable stimulation during activities of daily living.
Medtronic said 82% of subjects reported 50% or more reduction in low-back pain intensity. They registered a mean reduction of 67%. Half of the patients (32) reduced or stopped the use of opioid medications.
With the closed-loop feature on, patients only made one median adjustment to programming every 30 days. Medtronic said a comparison with a U.S. SCS market research survey across multiple manufacturers showed that 50% of those participants made frequent adjustments, at least a few times per week.
Finally, Medtronic reported 100% satisfaction with CL-SCS therapy. The company said 98% reported that they would recommend it to friends and family.
The study met its primary (at least a 50% reduction in overstimulation with the CL feature on vs. off at one month) and secondary (proportion of patients with at least a 50% reduction in overall, back, leg or upper limb (UL) VAS scores at 3 months) endpoints. Investigators plan for 18- and 24-month follow-up.
“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 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.”
