Medtronic Earns EU Nod for Inceptiv Spinal Cord Stimulator

Medtronic has earned CE mark approval for its Inceptive closed-loop, rechargeable spinal cord stimulator (SCS).
 
Medtronic said it’s the first of its SCS devices to offer a closed-loop feature that senses biological signals and adjusts stimulation moment to moment, as needed. Inceptiv can sense the body’s neural response to stimulation 50 times per second. As response increases—such as when the patient coughs, sneezes, or bends—Inceptiv automatically decreases stimulation.
 
As neural response decreases, stimulation returns to the pre-set optimal level to provide consistent therapy.
 
“Today, fixed-output spinal cord stimulation does not account for patient movements, which can alter the distance between the spinal cord and implanted epidural leads,” Dirk Rasche, M.D., from the Department of Neurosurgery, University Hospital of Schleswig-Holstein in Lübeck, Germany, told the press. “This can compromise the patient´s experience and therapeutic effectiveness. The Inceptiv closed-loop feature will allow for a more consistent and optimal delivery of therapy, and reduced need for manual programming adjustments by the patient. Together with the compatibility of multiple types of waveform options, inclusive of DTM SCS, and industry-leading MRI access, I believe this latest generation of rechargeable neurostimulator represents a significant leap forward in SCS therapy and a milestone of modern neuromodulation.”
 
Inceptiv uses a closed-loop capability with ECAPs (evoked compound action potentials). ECAPs measure how much neural tissue is activated in the spinal cord in response to electrical stimuli for real-time info that enables the system to respond to patient movements.
 
In a clinical study, nine of ten patients preferred the optional closed-loop setting compared to fixed-output stimulation. The company said Inceptiv is the only SCS system in Europe that offers both 1.5T and 3T MRI access. It’s also the thinnest SCS device in the world at 6 mm according to Medtronic, and uses the company’s proprietary DTM spinal cord stimulation.
 
The system’s battery can by recharged from empty to full in about an hour. Inceptiv will be commercially available in Europe in the coming months, Medtronic said.
 
“Medtronic pioneered SCS for pain management more than 50 years ago, and we continue to deliver new innovations that personalize care and improve pain relief for patients,” said Ash Sharan, M.D., chief medical officer, of Medtronic’s Neuromodulation business. “This approval marks the beginning of a new era of pain relief, using sensing technology to listen to the unique biological signals of each patient.”