Dive Brief
Medtronic has received Food and Drug Administration approval for its Inceptiv closed-loop spinal cord stimulator (SCS) for the treatment of chronic pain, the company said Friday.

The closed-loop system is meant to reduce overstimulation compared to the open-loop technology used by Medtronic’s rivals, such as Abbott, Boston Scientific and Nevro.

Evercore ISI analysts think Medtronic has lost share to Abbott over the past two years, and the launch of Inceptiv could help the company regain ground in the coming quarters.

Dive Insight
Users of open-loop SCS receive a predetermined amount of stimulation, which is set when the physician programs the device, regardless of what the patient is doing. The fixed output can result in moments of overstimulation that are uncomfortable, potentially leading users to choose a lower, less effective level of stimulation. Open-loop efficacy may fall over time, too.

Closed-loop systems, such as Medtronic’s Inceptiv device, adjust their output in real time based on signals from the body. Users set a target level of spinal cord activation and the system tweaks its output after every pulse to adapt to actions like laughing, bending or sneezing. Medtronic reported benefits to the approach in a small clinical trial in January.

Saluda Medical received FDA approval for a closed-loop device in 2022 but the big, publicly traded SCS companies have only provided open-loop systems.

Medtronic said it will launch Inceptiv in the U.S. in the coming weeks.

Evercore analysts estimate Abbott’s neuromodulation unit has grown more than 15% in each of the past four quarters. Medtronic’s estimated growth rate has ranged from just above 1% to just below 4% over the same period, leading the analysts to conclude the company has lost share to Abbott.

The approval of Inceptiv offers an opportunity to reverse the trend.

“[Medtronic’s] approval is the first closed loop approval amongst the big players in the market,” the analysts said. “Historically, the SCS stim market has reacted well to new tech. ... We think [Medtronic] could recoup lost share over the coming [quarters].”

Source:
https://www.medtechdive.com/news/medtronic-fda-approval-inceptiv-spinal-cord-stimulation/714528/