Medtronic receives FDA approval for Inceptiv neurostimulator

3 May 2024

Medtronic announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv rechargeable neurostimulator with closed-loop technology for the treatment of chronic pain. The Inceptiv System is Medtronic's first neurostimulator with closed-loop technology that senses the patient's unique biological signals and automatically adjusts stimulation in real time.

A neurostimulator is a medical implant the size of a stopwatch, similar to a pacemaker. The neurostimulator delivers light electrical pulses into the space around the spinal cord via one or more lead wires. These pulses disrupt the pain signals between the spinal cord and the brain, thus providing pain relief.

Automatic stimulation level adjustment

With traditional neurostimulators, these pulses are delivered continuously, which can be unpleasant with certain movements. This can cause patients to reduce stimulation, making neurostimulation less effective. The new Inceptiv neurostimulator measures the body's neural response 50 times per second. As the neural response increases, for example when the patient coughs or sneezes, Inceptiv automatically reduces stimulation. If the neural response decreases, the stimulation is increased again to the optimal level. This way, the stimulation is continuously adjusted to what the patient needs.

This automatic adjustment of the stimulation level is not entirely new, because a few years ago the Australian Saluda Medical launched the Evoke ECAP system. This system registers what happens in the spinal cord and adjusts the amount of electrical pulses accordingly. The Bravis hospital started using that system in December 2020.

Closed loop technology

Inceptiv is equipped with closed-loop technology with evoked compound action potentials (ECAPs). ECAPs are the signals that the spinal cord generates in response to electrical stimuli and that allow the stimulation to be adapted to the patient's activities. In a clinical study, nine out of ten patients preferred the closed-loop function to a fixed stimulation level.

According to Medtronic, Inceptiv is the first and only SCS system with full-body 1.5T and 3T MRI labeling, as well as the world's smallest and thinnest fully implantable SCS device designed for patient comfort. Medtronic will begin launching Inceptiv in the US in the coming weeks. The system was previously approved for sale in Europe and Japan.

Technology, data and AI

As a global leader in medical technology, Medtronic has been developing and implementing cutting-edge technology aimed at relieving pain, restoring health and extending life for 75 years. In light of the current challenges of keeping the highest quality of care accessible and affordable in a sustainable way, the smart application of technology, data and AI is more crucial than ever.