The US Food and Drug Administration (FDA) has approved Medtronic’s Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator to treat chronic pain related to diabetic peripheral neuropathy (DPN).
DPN is a neurological disorder that impacts around 30% of people with diabetes.
The approval offers DPN patients access to Medtronic’s spinal cord stimulation (SCS) portfolio of both rechargeable and recharge-free platforms.
These platforms include multiple programming options for customising patient treatment, unrestricted MRI access and the Medtronic TYRX neuro absorbable antibacterial envelope.
The company stated that the TYRX antibacterial envelope has been shown to stabilise the placement of the device while reducing more than 60% of infections.
It also noted that clinicians may advise patients to use CareGuidePro, a virtual guide for patients using SCS offerings.
Medtronic Neuroscience Portfolio neuromodulation business pain therapies vice-president and general manager Charlie Covert 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 company’s estimates, up to 800,000 patients in the US suffer from moderate to severe DPN symptoms that do not get resolved through conventional medical management approaches, such as drugs.
It considers such patients as potential candidates for SCS, which in turn represents an annual market opportunity of around $1.8bn.
The firm estimates that the market revenue for SCS treatment of chronic pain related to DPN is around $70m in the US. This figure is expected to increase to $300m by 2026.
Recently, Medtronic agreed to acquire medical technology company Affera in a deal valued at $925m.