Only MR-Conditional Rechargeable Spinal Cord Stimulator With Burst Stimulation Gets CE Mark

St. Jude Medical, Inc. has gained CE Mark approval for magnetic resonance imaging (MRI) conditional labeling for the 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.


Nearly 95 million Europeans suffer from chronic pain, and the condition is estimated to cost 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.

Spinal cord stimulation (SCS) is a proven therapy used to manage chronic pain. It uses a small implanted generator to deliver electrical pulses to the nerve fibers of the spinal column via leads with electrodes. These electrical pulses mask or interrupt pain signals as they travel up the spinal cord to the brain, reducing pain sensation. St. Jude Medical’s propietary so-called Burst stimulation is a neurostimulation waveform that is engineered to mimic the natural firing patterns of the nerves in the body, and delivers closely-spaced pulses of electrical energy to a patient’s spinal cord to manage 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. That’s why this approval is seen as good news for these patients, offering SCS-based pain relief, while maintaining the option for patients who may need future head and extremity MRI scans.

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. The Penta lead is the industry’s only five-column paddle lead, which offers unmatched lateral coverage to finely control current and stimulate spinal nerves based specifically on patient need.

Physician comments

“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 Dr. Athanasios Koulousakis, 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.”

Company comments

“MRI compatibility in our Prodigy system answers a growing market demand for devices that enhance patient access to new stimulation modes and therapy options,” said Eric S. Fain, M.D., group president of St. Jude Medical. “MRI compatibility for head and extremity will reduce treatment limitations or restrictions for chronic pain patients who may have future MRI needs. We want patients to have access to the most advanced therapies and technologies to effectively and safely reduce their chronic pain.”

Source: Business Wire

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