Medtronic
(NYSE: MDT)
announced today that it received CE mark approval for its Inceptiv spinal cord stimulator (SCS).
Inceptiv, a closed-loop, rechargeable SCS, treats chronic pain. Medtronic said it’s the company’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the motions of daily life.
According to a news release, certain movements during SCS therapy may result in uncomfortable stimulation. That, in turn, can lead to patients turning down their device’s stimulation output, negating their therapy.
Conversely, Inceptiv senses the body’s neural response to stimulation 50 times per second, every second, every day. When neural response increases — for instance, during a cough or sneeze — Inceptiv automatically decreases stimulation. As neural response decreases, stimulation returns to the pre-set, optimal level. All this occurs seamlessly while patients perform a full range of daily activities.
Inceptiv utilizes a closed-loop capability with ECAPs (evoked compound action potentials) based on decades of Medtronic research. The closed-loop technology unlocks the ability to listen and respond to signals along the spinal cord. A clinical study showed that nine of 10 patients preferred the closed-loop option to fixed-output stimulation.
“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 Dr. Ash Sharan, chief medical officer of the Neuromodulation unit at Medtronic. “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.”
More about the Medtronic Inceptiv system
Medtronic said its device is the only SCS system in Europe offering both full-body 1.5T and 3T MRI access. Most people using SCS need an MRI within five years of receiving their device, the company said.
Additionally, Inceptiv is the thinnest SCS device in the world at 6 mm, the company said. Its rechargeable battery can go from empty to full in approximately one hour, too.
Medtronic plans to make Inceptiv commercially available in the coming months in Europe. It remains unapproved for sale or distribution in the U.S.
“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,” said Dr. Dirk Rasche of the Department of Neurosurgery, University Hospital of Schleswig-Holstein in Lübeck, Germany. “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.”