Medtronic announces FDA approval of spinal cord stimulation therapy for treating chronic pain resulting from DPN

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

Medtronic estimates that up to 800,000 US patients suffer from moderate to severe DPN symptoms that are not resolved through conventional medical management approaches, like drugs. The company views these patients as potential candidates for spinal cord stimulation (SCS).

Charlie Covert, vice president and general manager of pain therapies at Medtronic, said: “DPN is a significant challenge for patients with diabetes, leading to disability and a diminished quality of life. 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.”

Independent studies show patients with DPN achieve significant pain relief when treated with SCS compared to conventional treatments alone1,2. A recent meta-analysis showed a significant improvement in health-related quality of life in patients treated with SCS compared to those receiving only conventional treatments3.

References: 

1. de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial. Pain. 2014 Nov;155(11):2426-31.

2. Slangen R, Schaper N, Faber C, et al. Spinal Cord Stimulation and Pain Relief in Painful Diabetic Peripheral Neuropathy: A Prospective Two-Center Randomized Controlled Trial. Diabetes Care. 2014;37:3016-3024.

3. Duarte RV, Nevitt S, Maden M, et al. Spinal cord stimulation for the management of painful diabetic neuropathy: a systematic review and meta-analysis of individual patient and aggregate data. Pain. March 2021.


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