FDA Approves St. Jude Medical’s Upgradeable, MRI-Compatable Spinal Cord Stimulation System

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St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads, which have received MR-conditional labeling for use with the Protégé MRI system for chronic pain treatment. According to the press release, the Protégé MRI system is the world’s smallest available MR-conditional SCS implantable pulse generator, as well as the only device to allow patients to safely undergo head and extremity MRI scans. Additionally, the press release states that it is the only device to offer software upgrades as an alternative to surgical device replacement.

“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,” said Dr. Eric Fain, group president of St. Jude Medical.

The press release notes that SCS therapy can offer proven chronic pain relief for many patients while reducing or even eliminating the use of pain medication. According to the press release, spinal cord stimulation therapy utilizes a small implanted generator to deliver electrical impulses to the nerve fibers of the spinal column via thin wires, or leads, with electrodes; the electrical pulses reduce the sensation of pain by masking or interrupting pain signals travelling up the spinal cord to the brain.

St. Jude Medical has also stated that it plans to seek updated labeling for several existing products, including the Penta™ paddle lead, to enable more patients to safely undergo MRI scans. The company also indicated that it plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.

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