The US Food and Drug Administration (FDA) has granted approval for St Jude Medical’s Protégé MRI spinal cord stimulation (SCS) system.
The company also secured FDA approval for MRI compatibility of its 60cm Octrode percutaneous leads, which can be used for MR-conditional labelling with the Protégé MRI system.
According to the company, the Protégé MRI system is the smallest MR-conditional SCS implantable pulse generator (IPG) available in the US and the only upgradeable IPG, which helps patients to safely undergo head and extremity MRI scans.
Following approval, the upgradeable technology enables patients to access future SCS technology from the company through software updates rather than surgical device replacement.
Marcus Neuroscience Institute director Robert Levy said: “The launch of the Protégé MRI system provides physicians with a solution that offers the benefits of future therapy upgrades as they are approved without the need for a future surgery.
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“The Protégé MRI system is an innovative technology advancement that optimises chronic pain care without compromising a patient’s potential need for future head and extremity MRI scans.”
The company said SCS therapy can provide proven, meaningful chronic pain relief for many patients, while improving quality of life and reducing or even eliminating a patient’s use of pain medication.
St Jude Medical group president Dr Eric Fain said: “With the approval of the Protégé MRI system, St Jude Medical has helped remove a barrier for some patients who may benefit from SCS therapy, while preserving the ability of those patients to access future technology and therapy advancements wirelessly through upgradeable technology.
“Going forward, patients implanted with a Protégé MRI system will not only have the ability to access future upgrades, but will also have the ability to undergo head and extremity MRI scans.”
The company is also planning to seek updated labelling for several existing products worldwide, including its Penta paddle lead, in a bid to allow patients to safely undergo MRI scans.
The company also plans to submit testing data supporting full-body MRI conditional scan labelling for future SCS systems.
Image: St Jude Medical’s Protege MRI implantable pulse generator. Photo: courtesy of Business Wire / St Jude Medical Inc.