Medtronic Says Inceptiv Spinal Cord Stimulator With Closed-loop Sensing Gets CE Mark Approval

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Medtronic Says Inceptiv Spinal Cord Stimulator With Closed-loop Sensing Gets CE Mark Approval

(RTTNews) - Healthcare technology firm Medtronic plc (MDT) on Friday received CE (Conformité Européenne) Mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS).

It is the first Medtronic SCS device to offer a closed-loop feature that senses each person's unique biological signals and adjusts stimulation moment to moment, as needed, to keep therapy in harmony with the motions of daily life.

Spinal cord stimulators deliver mild electrical impulses to the spinal cord, which can disrupt pain signals before they reach the brain.

The Inceptiv device utilizes a closed-loop capability with ECAPs (Evoked Compound Action Potentials), resulting from decades of Medtronic research and development to unlock the ability to listen and respond to signals along the spinal cord. In a clinical study, 9 out of 10 patients preferred the optional closed-loop setting compared to fixed-output stimulation.

The Inceptiv neurostimulator is the only SCS system in Europe offering both full-body 1.5T and 3T MRI access. Inceptiv is also the thinnest SCS device in the world at just 6mm. The system's battery can be recharged from empty to full in approximately one hour.

The Inceptiv SCS system will be commercially available in the coming months in Europe but is not approved for sale or distribution in the United States.

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