FDA Clears Inceptiv, a Closed-Loop Spinal Cord Stimulator for Chronic Pain

The Food and Drug Administration (FDA) has approved the Inceptiv^™ closed-loop rechargeable spinal cord stimulator (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.

Compared with traditional SCS devices, the closed-loop feature of the Inceptiv SCS senses neural responses (50 times per second) and is able to automatically adjust stimulation in real time, providing more consistent therapy. The device is implanted through a minimally invasive procedure and utilizes signals generated by the spinal cord in response to electrical stimuli (evoked compound action potentials), which allows a proprietary algorithm to respond and make adjustments in order to maintain the physician’s prescribed stimulation.

The Inceptiv system also offers full-body 1.5T and 3T MRI access with no power or impedance restrictions.

“For patients dealing with chronic pain, every day is a struggle,” said David Carr, vice president and general manager, Pain Interventions within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. “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.”

The Inceptiv SCS is expected to be available in the coming weeks.