Medtronic Introduces CE Mark Approved Inceptiv™ Closed-Loop Spinal Cord Stimulator for Chronic Pain Relief

Saturday, August 26, 2023

Medtronic plc, a renowned global player in healthcare technology, has obtained the CE(Conformité Européenne) Mark clearance for its groundbreaking Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS). This innovative device stands out as the inaugural entry in Medtronic's SCS portfolio to integrate a closed-loop feature that can interpret individual biological signals, facilitating real-time adjustments to stimulation based on the wearer's movements.†

The core function of spinal cord stimulators involves delivering gentle electrical impulses to the spinal cord to intercept pain signals before they reach the brain. Traditional stimulators can lead to discomfort during specific activities, causing some patients to lower the stimulation levels, which may compromise the efficacy of therapy. In contrast, Inceptiv's pioneering feature continuously senses neural responses at a frequency of 50 times per second, promptly adapting stimulation in response to ongoing movements. This dynamic adaptation decreases stimulation during actions like sneezing, coughing, or bending, and seamlessly restores optimal levels as neural responses normalize, ensuring consistent therapy during diverse daily tasks.

Dr. Dirk Rasche, associated with the Department of Neurosurgery at the University Hospital of Schleswig-Holstein in Lübeck, Germany, emphasized the pivotal role of this advancement: "Conventional fixed-output spinal cord stimulation neglects to consider patient movements, potentially impacting the distance between the spinal cord and implanted epidural leads. The Inceptiv closed-loop feature guarantees a more dependable and effective therapy delivery, reducing the necessity for manual patient adjustments. With its compatibility with various waveform options, including DTM™ SCS, and its leading MRI accessibility, this new-generation rechargeable neurostimulator signifies a remarkable leap in SCS therapy and neuromodulation."

At the core of Inceptiv's functionality is its closed-loop capability that utilizes Evoked Compound Action Potentials (ECAPs). Crafted through extensive Medtronic research, this technology empowers the system to comprehend signals along the spinal cord and respond instantaneously. ECAPs offer real-time insights into neural tissue activation following electrical stimuli, enabling the device to adapt to variations in patient movements. A clinical study demonstrated that 9 out of 10 patients preferred the optional closed-loop setting over fixed-output stimulation.1

Dr. Ash Sharan, Chief Medical Officer of Neuromodulation within Medtronic's Neuroscience Portfolio, emphasized the groundbreaking nature of the device: "Medtronic's legacy in pain management spans over 50 years, marked by innovations that personalize care and enhance pain relief. This clearance marks the inception of a new era in pain alleviation, harnessing sensing technology to discern each patient's unique biological signals."

Inceptiv sets an unparalleled standard by being the sole SCS system in Europe that offers comprehensive 1.5T and 3T MRI compatibility.‡ Given that the majority of SCS recipients necessitate an MRI within five years,2 this feature holds immense significance. Moreover, Inceptiv boasts a groundbreaking slimness at 6mm, coupled with the established benefits of Medtronic's proprietary DTM™ spinal cord stimulation. The device's battery can be fully recharged within approximately an hour, ensuring minimal disruption to therapy.

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