FDA Approves Medtronic’s Inceptiv Closed-Loop Spinal Cord Stimulator

Krishnan Chakravarthy, MD, PhD

According to a recent announcement, the FDA has approved Medtronic’s closed-loop rechargeable spinal cord stimulator (SCS), Inceptiv, as a new treatment for chronic pain. With the decision, the SCS device becomes the first on market to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in sync with daily activities of living.¹

While traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain, Inceptiv SCS constantly maintains the physicians prescribed stimulation that is tailored to the patient’s needs. The therapy includes a specialized circuitry and a proprietary algorithm to detect evoked compound action potentials (ECAPs), which are a direct measure of how much nerve tissue is activated in the spinal cord. It then senses the body’s response to stimulation 50 times per second and instantly increases or decreases stimulation to maintain prescribed settings.

"Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment," Krishnan Chakravarthy, MD, PhD, director of Innovative Pain Treatment Solutions and Surgery Center, VA San Diego Healthcare, and chairman of the Empower You Chronic Pain Foundation, said in a statement.¹ "Inceptiv listens to what the body is saying and, more quickly than you can blink, it seamlessly adjusts. This represents an important leap forward for the treatment of chronic pain."

With the approval, Inceptiv becomes the only approved closed-loop SCS that offers full-body 3T MRI access. After already receiving approvals in Europe and in Japan, Medtronic expects Inceptiv to be launched in the US in the coming weeks. The treatment is also paired with CareGuidePro, a mobile application web portal that serves as a virtual guide throughout a patient’s therapy journey.

"Inceptiv has been years in the making, so we are absolutely thrilled to now have FDA approval following earlier rollouts in Europe and Japan,” David Carr, vice president and general manager, Pain Interventions within the Neuromodulation business, Neuroscience Portfolio, Medtronic, told NeurologyLive^®.

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Previously, at the 2024 North American Neuromodulation Society (NANS) Annual Meeting, a late-breaking, EU-based, post-marketing study highlighted the benefits Inceptiv brings to patients. The prospective study included 2 parts: in-clinic testing for primary end point assessment with a randomized, crossover, single-blind design at 1 month, and a long-term follow-up for pain outcomes as 3-, 6-, 12-, 18-, and 24-months post device activation. Among the key findings, results showed that the study met its primary objective, with 89% of patients reporting a significant reduction in overstimulation relative to open loop (n = 28; P <.001), and 86% reporting a preference for closed-loop blinded testing at 1 month. The trial also met its secondary objective, with 86% of participants (n = 51) reporting at least 50% reduction in overall back and leg pain at 3 months.²

Additional data from the study showed clinically meaningful improvements in pain, physical function, and quality of life at 3 months with Inceptiv. At the same time point, over 80% of patients (n = 54) were able to achieve their stated activity goals for daily living with SCS therapy without fear of pain or therapy adverse effects. Although the study did not include a weaning protocol, 35% of patients (n = 37) on opioids at baseline reduced/stopped use at 3 months, and morphine milligram equivalent reduced from 73.5 to 54.0.

"Patients with high impact chronic pain struggle to do even basic things that most of us take for granted. For them, spinal cord stimulation often represents the last available therapy option when other more conservative measures have failed. But traditional fixed-output SCS may result in brief moments of uncomfortable overstimulation," Carr added. "Inceptiv SCS aims to solve this by sensing the body’s response to stimulation 50 times per second and automatically adjusting stimulation to maintain prescribed settings. With Inceptiv, we believe we are ushering in a new era for spinal cord stimulation."

In the post-marketing study, 77% reduction in chronic low back pain at 24 months was observed in Inceptiv-treated patients. Additionally, 93% of these individuals were considered responders on leg pain and 95% of patients were satisfied or very satisfied with SCS treatment at 24 months. Furthermore, investigators observed a significant average reduction of more than 26 points on Oswestry Disability Index, a measure of disability, with Inceptiv.

"Inceptiv is the most cutting-edge SCS solution available today, with its closed-loop capability, full-body 1.5T and 3T MRI access, compatibility with multiple types of waveforms, and tiny form factor that makes it the smallest and thinnest on the market. These features together make Inceptiv the most advanced closed-loop spinal cord stimulator available today," Carr said.

REFERENCES
1. Medtronic receives FDA approval for Inceptiv closed-loop spinal cord stimulator. News release. April 26, 2024. Accessed April 29, 2024. https://news.medtronic.com/2024-04-26-Medtronic-receives-FDA-approval-for-Inceptiv-TM-closed-loop-spinal-cord-stimulator
2. Medtronic highlights new clinical data demonstrating benefits of spinal cord stimulation in two late-breaking presentations at the North American Neuromodulation Society (NANS) Annual Meeting 2024. News release. Medtronic. January 18, 2024. Accessed April 29, 2024.
https://news.medtronic.com/2024-01-18-Medtronic-highlights-new-clinical-data-demonstrating-benefits-of-spinal-cord-stimulation-in-two-late-breaking-presentations-at-the-North-American-Neuromodulation-Society-NANS-Annual-Meeting-2024