FDA Approves Miniature Spinal Cord Stimulation System from St. Jude Medical

St. Paul, Minn.-based medical device maker St. Jude Medical Inc. has earned U.S. Food and Drug Administration (FDA) approval for its Protégé MRI spinal cord stimulation system. In addition to this approval, the company has also secured FDA approval for MRI (magnetic resonance imaging) compatibility of the company’s 60 cm Octrode percutaneous leads, which has received MR-conditional labeling for use with the Protégé MRI system. MR-conditional means that the device is safe for MRI scanning under certain proven conditions.

According to St. Jude, the Protégé MRI system is the smallest MR-conditional SCS (spinal cord stimulator) implantable pulse generator (IPG) available in the United States, and the only upgradeable IPG on the market to allow patients to safely undergo head and extremity MRI scans. Upgradeable technology allows patients to access future SCS technology from St. Jude Medical, once approved, through software updates rather than surgical device replacement. Historically, most patients would need additional surgery to receive new product features and benefits.

“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,” said Robert Levy, M.D., Ph.D., director of the Marcus Neuroscience Institute in Boca Raton, Fla. “The Protégé MRI system is an innovative technology advancement that optimizes chronic pain care without compromising a patient’s potential need for future head and extremity MRI scans.”

Chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. In total, the condition costs the American population 515 million workdays annually and generates upwards of 40 million visits to physicians each year.

SCS therapy can offer 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. Yet for some patients battling chronic pain, the possible need for future MRI scans has acted as a barrier to SCS therapy.

“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 Eric S. Fain, M.D., group president of St. Jude Medical. “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.”

In addition to the approval of the Protégé MRI system, St. Jude Medical also plans to seek updated labeling in key markets around the world for several existing products, including their flagship Penta paddle lead, in order to allow more patients the ability to safely undergo MRI scans. St. Jude Medical also plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.