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).
This new indication offers patients with DPN access to Medtronic’s industry-leading SCS portfolio of rechargeable and recharge-free platforms, which include multiple programming options to personalise patient therapy, unrestricted magnetic resonance imaging (MRI) access, unrivalled battery chemistry and performance, and the Medtronic TYRX neuro-absorbable antibacterial envelope, a company press release states.
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.”
According to the release, independent studies show patients with DPN achieve significant pain relief when treated with SCS compared to conventional treatments alone, and 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.