Medtronic
(NYSE: MDT)
announced today that it received FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) system.
Inceptiv treats chronic pain and represents Medtronic’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.
The medtech giant also labeled it the world’s smallest and thinnest fully implantable SCS device. Medtronic plans to begin a U.S. market launch in the coming weeks. The system already has availability in Japan and Europe, with CE mark approval coming last August.
“A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront,” said David Carr, VP and GM, Pain Interventions within the Neuromodulation business at Medtronic. “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.”
More about the Medtronic Inceptiv SCS system
Traditional methods deliver constant, mild electrical impulses. Medtronic says that certain movements during this type of SCS therapy may result in uncomfortable stimulation. That, in turn, can lead to patients turning down their device’s stimulation output, negating their therapy.
Inceptiv instead 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.
According to a news release, Inceptiv senses the body’s response to stimulation 50 times per second. Beyond its closed-loop capabilities, it features significant access to diagnostic imaging. It enables 1.5T and 3T full-body MRI access with no power or impedance restrictions. Medtronic said it’s the only FDA-approved closed-loop SCS offering full-body 3T MRI access.