- Medtronic’s closed-loop spinal cord stimulation (SCS) technology has reduced overstimulation in a clinical trial, the company said last week at the North American Neuromodulation Society annual meeting in Las Vegas.
- Most (89%) of the 28 participants reported a significant reduction in overstimulation compared to open-loop SCS, and 86% expressed a preference for closed-loop during blinded testing at one month.
- Medtronic’s closed loop SCS device, Inceptiv, has a CE Mark but is not currently approved in the U.S. Saluda Medical received approval for a closed-loop system that adjusts stimulation in response to feedback from the body in 2022, but the open-loop method remains the standard approach.
Patients and healthcare providers set the stimulation levels of the current open-loop SCS systems. Once the level is set, the device provides a fixed amount of stimulation until it is manually adjusted. In contrast, users of closed-loop systems set a target level of spinal cord activation and the device adjusts its output after every pulse based on signals from the body.
When Medtronic received a CE mark for its Inceptiv closed-loop device in August, it said the technology senses the neural response to stimulation 50 times per second. If the response increases, for example when the patient coughs, the device decreases stimulation. The goal is to avoid uncomfortable levels of overstimulation that can lead patients to reduce the output of their devices.
Medtronic is running a clinical trial in Australia to evaluate its closed-loop device. Subjects were treated with closed- and open-loop devices in a randomized, cross-over, single-blind trial for one month. After that, Medtronic began evaluating long-term pain outcomes in a single-arm trial of its closed-loop device.
The company saw “clinically meaningful improvements were observed in pain, physical function and quality of life at three months with closed-loop SCS.” Most (86%) of participants reported a 50% or more reduction in overall back and leg pain at three months.
“These early promising results suggest that closed-loop SCS may offer real benefits over fixed-output stimulation,” Marc Russo, lead investigator and director of Hunter Pain Specialists in Newcastle, Australia, said in a statement. “Could closed-loop SCS eventually become the standard of care? More data is needed, but what we are seeing thus far is encouraging.”
Medtronic is yet to win approval for Inceptiv in the U.S. The Food and Drug Administration approved Saluda’s Evoke device in 2022, but payer coverage remains a point of contention.
The Centers for Medicare and Medicaid Services agreed to provide temporary enhanced reimbursement in 2022 by approving a transitional pass-through payment for Evoke. However, Cigna has classified closed-loop SCS technology as “experimental, investigational, and/or unproven,” prompting pushback in November from medical professionals.
Medtronic shared data on its closed-loop system alongside the results of a 24-month European clinical trial of its DTM SCS waveform. More back pain patients responded to the waveform than to conventional medical management.