St Jude Medical has received CE Mark approval for magnetic resonance imaging (MRI) conditional labelling of its Prodigy MRI chronic pain system with select leads.

Approval ensures patient access to the company’s chronic pain products, including Burst Stimulation, while maintaining the option for patients who may require head and extremity MRI scans in the future.

The Prodigy MRI system is claimed to be the market’s smallest MR conditional rechargeable implantable pulse generator and the industry’s sole MR conditional spinal cord stimulator (SCS) system that can deliver Burst Stimulation and the firm’s traditional tonic stimulation.

"MRI compatibility in our Prodigy system answers a growing market demand for devices that enhance patient access to new stimulation modes and therapy options."

Introduced to the market in 2014, Burst Stimulation is a proprietary neurostimulation waveform that functions independently from stimulation cycles and programming compared to other SCS systems.

The addition of Burst Stimulation to the company’s chronic pain portfolio offers patients access to a therapy proven to relieve pain more effectively than legacy SCS, while reducing or eliminating paresthesia for most patients.

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.

St Jude Medical group president Dr Eric Fain said: "MRI compatibility in our Prodigy system answers a growing market demand for devices that enhance patient access to new stimulation modes and therapy options.

"MRI compatibility for head and extremity will reduce treatment limitations or restrictions for chronic pain patients who may have future MRI needs."

Apart from the approval of Prodigy MRI, the company’s all Octrode percutaneous and Penta 5-column paddle leads received MR conditional labelling and have been cleared for use with the simulator.

In addition, the company intends to secure approval for updated labelling in key markets worldwide for additional chronic pain products and intends to submit testing data to support full-body MR conditional labelling for their future SCS system.

Approximately 95 million Europeans suffer from chronic pain, which costs European healthcare systems a total of €300bn annually due to associated medical costs, lost work days and social security and welfare payments.