FDA clears Medtronic's neurostimulator for diabetic peripheral neuropathy pain

Medtronic 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 personalise patient therapy, MRI access, battery chemistry and performance, and the Medtronic TYRX Neuro Absorbable Antibacterial Envelope. The surgical management of diabetic patients can be a challenge for health care providers as they often have additional risk factors and are at greater risk for infection. The TYRX antibacterial surgical mesh envelope has been shown to stabilise device placement and help reduce infection by over 60%. Clinicians may also advise patients to take advantage of CareGuidePro, which serves as a virtual guide for patients throughout their SCS journey.

Independent studies show patients with DPN achieve significant pain relief when treated with SCS compared to conventional treatments alone. Overall, 70% of patients receiving treatment with SCS experienced relief of their pain symptoms compared to 6% of patients receiving only conventional treatments. Those treated with SCS experienced a 53% average reduction in pain, compared to 0% among patients receiving only conventional treatments. 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 treatments. A long-term analysis of patients treated in one of the studies using Medtronic SCS technology showed 80% of patients treated with SCS continued to use their devices at five years to treat their pain.

Charlie Covert, vice president and general manager, Pain Therapies within the Neuromodulation business 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."