Medtronic Receives FDA Approval for Inceptiv™ Closed-Loop Spinal Cord Stimulator 

 // News

April 29  

Closed-loop sensing capability instantly and automatically adjusts therapy while  treating chronic pain

DUBLIN – Medtronic plc (NYSE:MDT), a global leader in healthcare  technology, today announced that the U.S. Food and Drug Administration (FDA) has  approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the  treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop  feature that senses biological signals along the spinal cord and automatically adjusts  stimulation in real time, keeping therapy in harmony with the motions of daily life. 

“Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment,” said Dr. Krishnan Chakravarthy, M.D., Ph.D., Director of Innovative Pain  Treatment Solutions and Surgery Center, VA San Diego Healthcare, and Chairman of the 

Empower You Chronic Pain Foundation. “Inceptiv listens to what the body is saying and,  more quickly than you can blink, it seamlessly adjusts. This represents an important leap  forward for the treatment of chronic pain.” 

Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt  pain signals before they reach the brain. As patients go about their daily lives, certain  movements such as laughing, bending, or sneezing may result in brief moments of  uncomfortable overstimulation. This in turn may lead some patients to turn down their  device’s stimulation output, resulting in a suboptimal therapy experience. 

By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician’s  prescribed stimulation that is tailored to a patient’s needs. Specialized circuitry and a  proprietary algorithm detect ECAPs (Evoked Compound Action Potentials), signals  generated by the spinal cord in response to electrical stimuli. ECAPs are a direct measure of  how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body’s response to stimulation50 times  per second and instantly increases or decreases stimulation to maintain prescribed settings  as determined by the physician.  

The Inceptiv system delivers additional advantages beyond its closed-loop capability.  Inceptiv offers unparalleled access to diagnostic imaging, with 1.5T and 3T full-body MRI  access with no power or impedance restrictions.It is the only FDA-approved closed-loop  spinal cord stimulator that offers full-body 3T MRI access. Up to 84% of SCS-implanted  patients are expected to need at least one MRI within five years of implant.1It is the world’s  smallest and thinnest fully implantable SCS device, designed for patient comfort. In addition, Inceptiv SCS allows the option of multiple types of waveforms, including Medtronic’s  proprietary DTM™ SCS therapy, which demonstrated an 84% responder rate at 12 months in  a large, multicenter randomized controlled trial (RCT).2,3 Patients with Inceptiv SCS can also  access CareGuidePro™, a mobile application and web portal that serves as a virtual guide  throughout their Medtronic spinal cord stimulation therapy journey. 

“A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS,  Medtronic is at the forefront,” said David Carr, vice president and general manager, Pain  Interventions within the Neuromodulation business, which is part of the Neuroscience  Portfolio 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.”  

Medtronic will initiate the U.S. market launch of Inceptiv in the coming weeks. The system  previously earned approvals for sale in Europe and in Japan. For more information, visit  

† Sensing signals may not be measurable in all cases  

‡ Under certain conditions. Refer to product labeling for full list of conditions. 

About Medtronic 

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin,  Ireland, is the leading global healthcare technology company that boldly attacks the most  challenging health problems facing humanity by searching out and finding solutions. Our  Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+  

passionate people across 150 countries. Our technologies and therapies treat 70 health  conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools,  patient monitoring systems, and more. Powered by our diverse knowledge, insatiable  curiosity, and desire to help all those who need it, we deliver innovative technologies that  transform the lives of two people every second, every hour, every day. Expect more from us  as we empower insight-driven care, experiences that put people first, and better outcomes  for our world. In everything we do, we are engineering the extraordinary. For more  information on Medtronic (NYSE:MDT), visit, and  follow Medtronic on LinkedIn. 

Any forward-looking statements are subject to risks and uncertainties such as those  described in Medtronic’s periodic reports on file with the Securities and Exchange  Commission. Actual results may differ materially from anticipated results.

Success message!
Warning message!
Error message!