Medtronic has received the US Food and Drug Administration (FDA) approval for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) to treat chronic pain.
Inceptiv is the company’s first SCS device that provides a closed-loop function, where biological signals along the spinal cord are measured to automatically adjust stimulation in real-time.
The SCS system senses the body’s response to stimulation 50 times per second, and instantly adjusts the stimulation to maintain the settings prescribed by the physician.
In addition to the closed-loop capability, the Inceptiv system delivers additional advantages including access to 1.5T and 3T full-body MRI, with no power or impedance restrictions.
The system also allows several types of waveforms, including Medtronic’s Differential Target Multiplexed (DTM) SCS therapy, which showed an 84% responder rate in a study.
Medtronic said Inceptiv is the only FDA-approved closed-loop system that offers full-body 3T MRI access, and the world’s smallest and thinnest implantable SCS device.
The Inceptiv SCS system, which is already approved in Europe and Japan, is planned to be commercialised in the US in the coming weeks.
Medtronic pain interventions vice president and general manager David Carr said: “A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront.
“For patients dealing with chronic pain, every day is a struggle. 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. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS.”
According to Medtronic, traditional, fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain.
When patients make certain movements, such as laughing, bending, or sneezing, the devices may create a short moment of uncomfortable overstimulation.
The overstimulation may lead some patients to turn down their device’s stimulation output, resulting in a suboptimal therapy experience.
Unlike traditional fixed-output SCS devices, Inceptiv senses biological signals and consistently maintains the physician’s prescribed stimulation, customised to a patient’s needs.
Also, the system keeps the therapy in harmony with the patient’s movements in daily life.
Its specialised circuitry and unique algorithm will detect Evoked Compound Action Potential signals (ECAPs) generated by the spinal cord in response to electrical stimuli.
ECAPs offer a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation.
Furthermore, patients with Inceptiv can also access CareGuidePro, a mobile application and web portal that acts as a virtual guide throughout their spinal cord stimulation therapy journey.
