Medtronic has secured FDA approval for its first closed-loop spinal cord stimulator, designed to take in signals from the body and adjust its therapy automatically.
The Inceptiv implant for chronic pain aims to keep pace with the body’s nerve activity as the patient goes through their daily life. According to the company, with traditional systems that deliver a constant level of mild electrical stimulation to disrupt pain signals, certain movements such as laughing, bending or sneezing may trigger periods of discomfort.
Medtronic said that Inceptiv SCS aims to sense the body's response to stimulation via the spine’s evoked compound action potentials—noting changes as many as 50 times per second—while increasing or decreasing its dosage with the goal of maintaining its overall prescription regimen.
The company also said the Inceptiv is the only FDA-approved closed-loop spinal cord stimulator compatible with 1.5 T and 3.0 T full-body MRI scans, under specific conditions. The system previously obtained approval in Japan, as well as a CE mark approval in Europe last August.
“A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront,” the company’s general manager of pain interventions, David Carr, said in a statement.
“For patients dealing with chronic pain, every day is a struggle,” Carr added. “They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide.”
Previously, the former Fierce 15 winner Saluda Medical collected FDA approval for its closed-loop spinal cord stimulator, the Evoke implant, in 2022. That device received a second approval for MRI-conditional labeling late last year, deeming it safe for 1.5 T or 3.0 T head and extremity scans, or 1.5 T full-body exams.
Medtronic estimates that as many as 84% of patients implanted with a spinal cord stimulator for chronic pain will also need to undergo at least one MRI scan within five years of the procedure.