Medical device firm St. Jude Medical has received approval from the US Food and Drug Administration (FDA) for its Protégé MRI spinal cord stimulation (SCS) system.
The Protégé MRI system is the smallest MR-conditional SCS implantable pulse generator (IPG) and the only upgradeable IPG, which helps the patients to safely undergo head and extremity MRI scans.
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 has also received FDA approval for MRI compatibility of its 60cm Octrode percutaneous leads. It can be used for MR-conditional labeling with the Protégé MRI system.
St. Jude is also planning to update labeling for several existing products across the globe, including its Penta paddle lead, in a bid to allow patients to safely undergo MRI scans.
In addition, the firm plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.
Image: St. Jude Medical’s Protege MRI implantable pulse generator. Photo: courtesy of St. Jude Medical, Inc.