FDA Approves Only Closed-Loop Spinal Cord Stimulator to Allow Full-Body 3T MRI
Reportedly the smallest and thinnest implantable spinal cord stimulator (SCS) device, the Inceptiv closed-loop SCS modality allows access to 1.5T and 3T full-body MRI without power restrictions.
It has been estimated that over 80 percent of patients with spinal cord stimulation (SCS) devices will require at least one magnetic resonance imaging (MRI) exam within a five-year period after implantation.1 Now the Food and Drug Administration (FDA) has approved a closed-loop SCS modality that allows full-body MRI without impedance or power restrictions.2
Approved for the treatment of chronic pain, the Inceptiv™ closed-loop rechargeable SCS (Medtronic) is the only FDA-approved device of its kind to allow full-body 3T MRI access, according to Medtronic.2
The Inceptiv™ closed-loop spinal cord stimulator (SCS) allows access to 1.5T and 3T full-body MRI without power restrictions. Medtronic, the manufacturer of the modality, added that the Inceptiv™ closed-loop SCS is the only FDA-approved device of its kind to allow full-body 3T MRI access. (Image courtesy of Medtronic.)
Combining a proprietary algorithm and specialized circuitry, Medtronic noted the Inceptiv™ closed-loop SCS detects evoked compound action potentials (eCAPs), direct measurements of activated nerve tissue in the spinal cord that allows automated modification of the stimulation provided by the device. Noting that the Inceptiv™ closed-loop SCS is the smallest, thinnest device of its kind, Medtronic emphasized that any MRI needs would not interrupt or inhibit the continuous pain relief provided by the SCS modality.
“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,” noted David Carr, a vice president and general manager, Pain Interventions, at Medtronic.
References
1. Desai MJ, Hargens LM, Breitenfeldt MD, et al. The rate of magnetic resonance imaging in patients with spinal cord stimulation. Spine. 2015;40(9):E531-7.
2. Medtronic. Medtronic receives FDA approval for Inceptiv™ closed-loop spinal cord stimulator. PR Newswire. Available at: https://www.prnewswire.com/news-releases/medtronic-receives-fda-approval-for-inceptiv-closed-loop-spinal-cord-stimulator-302128632.html . Published April 26, 2024. Accessed April 26, 2024.
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