Medtronic's Inceptiv rechargeable spinal cord stimulator (CSC) has been approved in the United States (US) by the Food and Drug Administration (FDA) for the treatment of chronic pain. The device captures biological signals through the spine, and adjusts the stimulation it delivers to these signals in real-time. This ensures that the action of the SCS better matches patients' symptoms. The Inceptiv already received a CE mark in the European Union (EU) in August.
An SCS is already a well-known method for relieving chronic pain. Traditional variants of an SCS deliver constant, mild electrical signals to the patient. These signals interrupt pain signals, preventing them from reaching the brain. In practice, this causes the patient to experience no or less pain.
Need for stimulation is not constant
However, the stimulation a patient receives in an optimal situation varies and depends on many factors. For example, if a patient laughs or sneezes, this can impact the pain they experience and therefore the need for stimulation through the SCS. However, consider also simply bending forward, for example to pick something up.
The fact that the stimulation provided by the SCS is not always optimally matched to needs not only causes pain. It can also cause the stimulation given off by an SCS to be permanently reduced, to prevent overstimulation. However, a consequence of this is also that the SCS's action is reduced, and patients experience less pain relief.
Evoked Compound Action Potentials
With the Inceptiv, Medtronic is responding. This innovative SCS measures biological signals and ensures that the stimulation it delivers is always precisely tailored to the patient's needs. In doing so, Medtronic uses a patented algorithm to detect so-called Evoked Compound Action Potentials (ECAPs). The body generates these signals in response to electrical stimulation.
Using ECAPs, it is possible to measure how much nerve tissue has been activated in the spine, and allows real-time adjustments to stimulation. Inceptiv performs this measurement 50 times per second, and adjusts the stimulation it gives accordingly in real-time.
No restrictions on imaging technology
Another advantage of the Inceptiv is that users of the device have unrestricted access to imaging technology, such as MRI scanners. According to Medtronic, it is the only FDA-approved closed-loop SCS that offers full-body 3T MRI access. This is an important consideration, as research shows that up to 84 per cent of patients with an SCS require at least one MRI scan within five years of implantation.
Author: Wouter Hoeffnagel
Image: Medtronic
