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August 24, 2015

St Jude Medical secures CE Mark approval for MRI conditional labelling of Prodigy system

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.

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.

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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.

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