Inceptiv™ Closed-Loop Spinal Cord Stimulator Receives U.S. FDA Approval for the Treatment of Chronic Pain

Chronic pain impacts people of all backgrounds and all walks of life. According to the CDC, chronic pain affects over 50M Americans, and more than 17M live with “high-impact” pain that detrimentally affects their daily lives. Traditionally, chronic pain management has included oral medications, injections, and occasionally surgical interventions. Spinal cord stimulation has emerged as a highly effective and safe alternative for pain relief.

Spinal cord stimulation is a proven therapy for treating certain types of chronic pain when conventional medical management efforts have failed. The technology has been around for over 50 years, with early research beginning in the 1960s and the first commercial models entering the market in the early 1980s, including one from Medtronic. While spinal cord stimulation is a well-established non-opioid treatment, for most of that history it has been “fixed output”, meaning stimulation did not adjust based on patient needs, moment to moment. New advances like Inceptiv™ SCS are changing that.

Pain is intensely personal, and stimulation therapy should be tailored to each individual’s needs. For people with chronic pain using SCS therapy, stimulation needs vary. For example, a laugh, cough or bending motion might lead to uncomfortable overstimulation in a more traditional device. Inceptiv, by contrast, is built to remain in harmony with the motions of daily life.

Inceptiv “listens” to the body, 50x per second, 24/7, adjusting stimulation based on individual needs. This “closed loop” technology is comparable to adaptive cruise control, or a thermostat. But the engineering feats required to capture these biosignals are significant and years in the making.

Inceptiv delivers closed-loop stimulation by capturing ECAPs (Evoked Compound Action Potentials), signals generated by neurons within the spinal cord in response to an electrical stimulus from the device. Based on the ECAP response it then automatically adjusts the intensity of the stimulation. This is important to SCS patients because as they go about their day, stimulation needs vary. Inceptiv is a groundbreaking “smart” closed-loop SCS for treating chronic pain.

Inceptiv’s FDA approval in April 2024 represented a pivotal advancement in the safe and effective treatment of chronic pain.