Medtronic Vanta recharge-free neurostimulator. Credit: Medtronic.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.