FDA approves new spinal-cord device for chronic pain, Medtronic says

By Bernard Turk On Apr 26, 2024

Medtronic said Friday that the U.S. Food and Drug Administration has approved a new spinal-cord implant that relieves chronic pain, a bid to expand into a patient population that relies heavily on medications like opioids.

The new device works by delivering an electrical pulse to the spinal cord, interrupting pain signals before they reach the brain in patients suffering from back, cervical and nerve damage. While earlier versions of the device provided a constant level of stimulation, Medtronic’s new product can read signals from nerve fibers and automatically adjust the intensity — a feature designed to avoid uncomfortable jolts when a patient sneezes, coughs or laughs.

“It’s like listening for whispers at a rock concert,” David Carr, a Medtronic vice president, said in an interview.

The approval comes at a challenging period for Medtronic, whose share price has fallen about 40 percent from its peak in 2021. Another company, Saluda Medical, already has FDA approval for a similar spinal-cord implant. Still, Medtronic executives have said their new device, called Inceptiv, is a game changer that they expect to “revolutionize” the market.

The use of spinal-cord stimulators has increased significantly over the past decade, although their use has been constrained by limited awareness from patients and primary-care doctors, said Justin Davanzo, a neurosurgeon with Allegheny Health in Pennsylvania.

Some patients report that if they bend or move a certain way, they feel “a zap or a zing down their back,” Davanzo said. Next-generation devices — like the ones developed by Saluda and Medtronic — could improve patient comfort, he said.

Medtronic’s Carr said that many patients struggle to find a comfortable balance with implants that deliver a relatively constant stimulation, and end up asking for the devices to be removed. Inceptiv, he said, is designed to work like “adaptive cruise control,” modifying the electrical pulse according to the body’s feedback.

Medtronic’s Inceptiv contains a lithium battery that can be recharged through the skin, and two leads with electrodes — some to read the signals from nerve fibers, and others to deliver the electrical pulse. The device can adjust the level of stimulation 50 times a second, according to the company.

Inceptiv is “the world’s smallest and thinnest fully implantable” spinal-cord stimulator, Medtronic said.

The product arrives amid increased awareness about the addictive nature of pain pills that helped ignite the nation’s opioid crisis. In recent years, however, stricter prescribing guidelines and regulations have led chronic pain patients to complain about the difficulties in obtaining their medications.

Stefan Kertesz, a professor at the Center for Addiction and Pain Prevention and Intervention, the University of Alabama at Birmingham, has been skeptical of older spinal-cord stimulators, noting limited evidence of their long-term benefit for pain. He is hopeful about the benefits of the new systems, citing studies that show they offer greater pain relief over legacy versions.

Still, he cautioned that pain management is complex. “Most people with severe chronic pain need care and the care is not going to be a quick technological fix,” Kertesz said.

He added: “For some people, it looks like these stimulators are incredibly helpful but I sincerely doubt many people will get these stimulators … sticking wires around your spinal cord is not something you do unless you are in desperate straits.”

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