St. Jude: CE Mark For MR-Conditional Rechargeable Spinal Cord Stimulator

(RTTNews) - St. Jude Medical Inc (STJ) on Monday announced CE Mark approval for magnetic resonance imaging ("MRI") conditional labeling for its Prodigy MRI chronic pain system with select leads.

Upon its launch, the Prodigy MRI system will become the market's smallest MR-conditional rechargeable implantable pulse generator ("IPG"), as well as the industry's sole MR-conditional SCS system capable of delivering both St. Jude Medical's proprietary Burst stimulation and traditional tonic stimulation.

In addition to the approval of Prodigy MRI, all Octrode percutaneous and Penta 5-column paddle leads have received MR-conditional labeling and are approved for use with Prodigy MRI.

Nearly 95 million Europeans suffer from chronic pain. SCS therapy can offer many patients meaningful pain relief and improvements in quality of life, yet for some patients the need for future MRI scans can act as a barrier to SCS therapy.

The new Prodigy MRI system will ensure patient access to St. Jude Medical's innovative portfolio of chronic pain solutions, such as the company's Burst stimulation, while maintaining the option for patients who may need future head and extremity MRI scans.

In addition to the approval of the Prodigy MRI system, St. Jude Medical has announced plans to seek updated labeling in key markets around the world for additional chronic pain products, and plans to submit testing data to support full-body MR-conditional labeling for their future SCS systems.

St. Jude Medical is the only company approved to offer patients Burst stimulation, which the company introduced to the market in 2014 with the launch of the original Prodigy chronic pain system. The therapy was introduced after nearly a decade of research and study in collaboration with Dr. Dirk De Ridder, who filed the therapy's initial patents in 2005.