St Jude Medical’s Prodigy MRI system approved for MR use

St Jude Medical has announced that its Prodigy MRI chronic pain system has been granted CE Mark approval for magnetic resonance imaging (MRI)-conditional labelling.

The system will be the smallest MR-conditional rechargeable implantable pulse generator available in Europe, as well as the only MR-conditional spinal cord stimulator system (SCS) capable of delivering Burst stimulation as well as traditional tonic stimulation.

Additionally, the Octrode percutaneous and Penta five-column paddle leads have received MR-conditional labeling and are approved for use with Prodigy MRI.

St Jude Medical also plans to seek updated labelling in key markets around the world for additional chronic pain products, with testing data to be submitted to support full-body MR-conditional labelling for future SCS systems.

Dr Eric Fain, group president of St Jude Medical, 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."

The firm's Tendril STS and IsoFlex Optim pacing leads were CE Mark-approved for MRI usage last year.