Medtronic gets USFDA approval of spinal cord stimulation therapy
Equipment

Medtronic gets USFDA approval of spinal cord stimulation therapy

Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone

  • By IPP Bureau | January 25, 2022

Medtronic announced it has received U.S. Food and Drug Administration approval of its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy (DPN).

DPN is a debilitating and progressive neurological disorder that affects approximately 30% of people with diabetes, significantly impacting both quality of life and functional ability, including mood, social relationships, and sleep. DPN occurs when high blood sugar (glucose) damages nerves in the body, most often in the legs and feet, leading to numbness and burning or stabbing pain. In some patients, the pain can become progressively worse and excruciating. Patients may be treated with medications, but they are often only partially effective and can result in serious side effects.

This new indication offers patients with DPN access to Medtronic's industry-leading spinal cord stimulation (SCS) portfolio of rechargeable and recharge-free platforms, which include multiple programming options to personalize patient therapy, unrestricted MRI access, unrivaled battery chemistry and performance, and the Medtronic TYRX Neuro Absorbable Antibacterial Envelope.

"DPN is a significant challenge for patients with diabetes, leading to disability and a diminished quality of life," said Charlie Covert, vice president and general manager, Pain Therapies within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "This new indication enables us to apply Medtronic's more than 40 years of proven SCS experience, as well as the company's deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients."

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