St. Jude Medical wins CE Mark for Prodigy MRI pain device

St. Jude Medical (NYSE:STJ) today said it added MR-conditional labeling to the CE Mark for its Prodigy spinal cord stimulator, which is designed to treat chronic pain. The approval means the company can market the device for patients who need head and extremity MRI scans.

Little Canada, Minn.-based St. Jude claimed the Prodigy MRI as the smallest MR-conditional rechargeable implantable pulse generator to hit the market. The company’s Prodigy device 1st won CE Mark approval in the European Union in March and gained a nod from Health Canada in May.

The Prodigy device is designed to stimulate the spinal cord with low-level bursts of electricity to interrupt or mask the transmission of pain signals to the brain, using both tonic and burst stimulation, St. Jude said. The burst technology may help reduce a sensation of tingling along the spinal cord associated with tonic stimulation called paresthesia, according to the company. It may also be effective in patients who become unresponsive to traditional spinal cord stimulation, St. Jude said.

European regulators also approved the Octrode percutaneous and Penta 5-column paddle leads for the MR-conditional labeling, St. Jude said, noting that it plans to seek similar labeling in “key markets” globally for more pain treatments, plus applications for full-body MR-conditional labeling for future SCS devices.

“MRI compatibility in our Prodigy system answers a growing market demand for devices that enhance patient access to new stimulation modes and therapy options,” group president Dr. Eric Fain said in prepared remarks. “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.”

“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,” added Dr. Athanasios Koulousakis of the 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.”

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