FDA approves Medtronic’s innovative spinal cord stimulator for chronic pain treatment

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced a significant advancement in the treatment of chronic pain with the U.S. Food and Drug Administration (FDA) approval of its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). This device represents a major leap forward in pain management technology, featuring the first-of-its-kind closed-loop system that automatically adjusts to the body’s signals to optimize pain relief continuously throughout the day.

Enhancing Patient Comfort and Therapy Effectiveness

The Inceptiv SCS system is designed to alleviate chronic pain by delivering mild electrical impulses to the spinal cord, which interrupt pain signals before they reach the brain. Traditional SCS devices provide constant stimulation, which can lead to moments of overstimulation during certain activities like bending or sneezing. The innovative Inceptiv system, however, adjusts the stimulation intensity in real-time based on the feedback from the body’s own biological signals, maintaining optimal therapy levels tailored to patient activities and postures.

Dr. Krishnan Chakravarthy, M.D., Ph.D., Director of Innovative Pain Treatment Solutions and Surgery Center at VA San Diego Healthcare, and Chairman of the Empower You Chronic Pain Foundation, praised the new device: “Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment. Inceptiv listens to what the body is saying and seamlessly adjusts. This represents an important leap forward for the treatment of chronic pain.”

Medtronic’s Inceptiv SCS, a pioneering spinal cord stimulator with closed-loop technology, receives FDA approval, offering a new standard in chronic pain treatment. Photo courtesy of Medtronic.

Technical Advancements and Patient Benefits

Inceptiv is not only groundbreaking in its adaptive technology but also in its design and compatibility with diagnostic tools. It is the world’s smallest and thinnest fully implantable SCS device, which enhances patient comfort. Moreover, it is the only FDA-approved closed-loop SCS that offers full-body 3T MRI access without power or impedance restrictions, addressing a critical need as up to 84% of SCS-implanted patients may require at least one MRI within five years of implantation.

Market Impact and Future Prospects

David Carr, Vice President and General Manager of the Pain Interventions sector within Medtronic’s Neuromodulation business, highlighted the broader implications of this innovation: “A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront. For patients dealing with chronic pain, every day is a struggle. They deserve personalized and effective relief, without compromising future access to MRI.”

Medtronic plans to initiate the U.S. market launch of Inceptiv in the coming weeks, offering a new, highly effective treatment option for millions suffering from chronic pain.

As Medtronic sets to roll out Inceptiv across the United States, this new technology is poised to transform the way chronic pain is managed, offering hope and enhanced quality of life to patients who have long sought more responsive and adaptable pain relief solutions.