The approval covers the Intellis rechargeable neurostimulator and the Vanta recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy.
The new indication offers DPN patients access to Medtronic’s spinal cord stimulation (SCS) portfolio of both rechargeable and recharge-free platforms. The platforms include multiple programming options for personalized patient therapy, unrestricted MRI access, strong battery chemistry and performance and the Medtronic TYRX neuro absorbable antibacterial envelope, according to a news release.
Fridley, Minnesota-based Medtronic said the TYRX antibacterial surgical mesh envelope has been shown to stabilize device placement and help reduce infection by over 60%. Patients using Medtronic’s SCS offerings can also be advised to use CareGuidePro, a virtual guide for the SCS journey.
The company said 70% of patients in independent studies who received treatment with SCS experienced relief of their pain symptoms, compared to 6% of patients receiving only conventional treatments. The SCS patients experienced a 53% average reduction in pain, compared to 0% of the conventional treatment group.
“DPN is a significant challenge for patients with diabetes, leading to disability and a diminished quality of life,” Medtronic VP and GM of Pain Therapies Charlie Covert said in the release. “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.”