St Jude Medical receives CE mark for MRI conditional labelling of the Prodigy MRI system


St Jude Medical has received CE mark approval for magnetic resonance imaging (MRI) conditional labelling for the company’s Prodigy MRI chronic pain system with select leads.

A company press release states that 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 spinal cord stimulation 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 labelling 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.

Nearly 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of €300bn annually due to associated medical costs, lost work days and social security and welfare payments. Spinal cord stimulation 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 such therapy.

The new Prodigy MRI system will ensure patient access to St Jude Medical’s 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 labelling in key markets around the world for additional chronic pain products, and plans to submit testing data to support full-body MR-conditional labelling for their future spinal cord stimulation 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 it may also need future MRI scans,” said Athanasios Koulousakis, head of Department Functional Neurosurgery, Spasticity and Pain, University Hospital in Cologne, Germany. “So while the number of spinal cord stimulation 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 spinal cord stimulation 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.”

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 Dirk De Ridder, who filed the therapy’s initial patents in 2005.

The addition of Burst stimulation to St Jude Medical’s chronic pain portfolio offered patients access to a therapy proven to relieve pain more effectively than traditional spinal cord stimulation while also significantly reducing or eliminating paraesthesia for most patients. Clinical studies have also shown Burst stimulation can also offer pain relief to patients who may have become unresponsive to traditional spinal cord 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,” said Eric S Fain, 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.”