St. Paul, Minn.-based St. Jude said the Protégé MRI approval is for MRI scans of the head and extremities for patients implanted with the device, claiming it as the smallest MR-conditional SCS implantable pulse generator in the U.S. and the only device to offer software upgrades as an alternative to surgical device replacement.
Last year the FDA granted pre-market approval for St. Jude’s Protégé SCS device.
"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," group president Dr. Eric Fain said in prepared remarks.
St. Jude said it’s also planning a bid for updated MR labeling in overseas jurisdictions for "several existing products" including the Penta paddle lead. The company also plans to submit data on full-body MRI labeling for "future SCS systems."