St. Jude Medical Gets CE Mark for MRI-Compatible Chronic Pain System

St. Paul, Minn.-based St. Jude Medical Inc.  has earned the CE mark for its magnetic resonance imaging (MRI) conditional labeling for the company’s Prodigy MRI chronic pain system with select leads. Upon its launch, the company claims 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 five-column paddle leads have received MR-conditional labeling and are approved for use with Prodigy MRI. The Penta lead is a five-column paddle lead that offers coverage to finely control current and stimulate spinal nerves based specifically on patient need.

Nearly 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of 300 billion Euro annually due to associated medical costs, lost work days and social security and welfare payments. 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.

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.

“Clinical experience suggests that while relief from chronic pain remains the primary need for patients seeking spinal cord stimulation therapy, some patients who may benefit from SCS therapy may also need future MRI scans,” said Athanasios Koulousakis, M.D., head of department functional neurosurgery, spasticity and pain, University Hospital in Cologne, Germany. “So while the number of SCS patients requiring future MRIs may be limited, it is still critical to remove barriers to diagnostic options. Yet just as critical is providing MRI capability in SCS solutions that provide access to new therapy options, such as St. Jude Medical’s Burst stimulation. The new Prodigy MRI system helps put all such requirements into one package for our patients.”