FDA Approval Granted for Medtronic's Inceptiv™ Closed-Loop Spinal Cord Stimulator

Monday, April 29, 2024

Medtronic plc has just received approval from the U.S. Food and Drug Administration (FDA) for its latest innovation in healthcare technology: the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS), designed to address chronic pain.

This groundbreaking device marks a significant advancement in pain management, as it is the first of its kind to incorporate a closed-loop feature, which continuously monitors biological signals along the spinal cord and automatically adjusts stimulation levels in real time, ensuring that therapy remains aligned with the patient's daily activities.

Director of Innovative Pain Treatment Solutions and Surgery Center at VA San Diego Healthcare, and Chairman of the Empower You Chronic Pain Foundation, expressed enthusiasm for this development, stating, "Pain management is deeply personal, and treatment should be adaptable to each patient's unique needs. Inceptiv responds to the body's signals swiftly and seamlessly, representing a significant leap forward in chronic pain treatment."

Unlike traditional SCS devices, which deliver constant electrical impulses to disrupt pain signals, Inceptiv SCS offers a more refined approach. It detects Evoked Compound Action Potentials (ECAPs), signals generated by the spinal cord in response to electrical stimuli, and adjusts stimulation accordingly.

With its ability to sense the body's response to stimulation 50 times per second, Inceptiv ensures that therapy remains optimized according to the physician's prescription, mitigating discomfort caused by overstimulation during daily activities.

The benefits of Inceptiv extend beyond its closed-loop functionality. It provides unparalleled access to diagnostic imaging, with full-body MRI compatibility at 1.5T and 3T without power or impedance limitations. Inceptiv boasts a compact design for patient comfort and offers multiple waveform options, including Medtronic's proprietary DTM™ SCS therapy, which has demonstrated promising results in clinical trials.

Pain Interventions within Medtronic's Neuromodulation business, emphasized the company's commitment to advancing spinal cord stimulation technology. "With Inceptiv SCS, we are ushering in a new era in pain management.

"Patients deserve personalized and effective relief without sacrificing access to essential diagnostic imaging. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS."

Medtronic is poised to launch Inceptiv in the U.S. market in the near future, following previous approvals for sale in Europe and Japan


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