FDA Approves Spinal Cord Stimulation System From St. Jude Medical

St. Jude Medical Inc. has received U.S. Food and Drug Administration approval of its Protégé MRI spinal cord stimulation system and for MRI compatibility of the company’s 60cm Octrode percutaneous leads, which has received magnetic resonance (MR)-conditional labeling for use with the Protégé system.

The Protégé MRI system is the smallest MR-conditional spinal cord stimulation (SCS) 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 magnetic resonance imaging (MRI) scans, St. Jude executives claim. 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 a 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, according to St. Jude Medical.

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 its flagship Penta paddle lead, to give 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.

Spinal cord stimulation is a therapy used to manage chronic pain. SCS therapy uses a small implanted generator to deliver electrical pulses to the nerve fibers of the spinal column via thin wires, knows as leads, with electrodes. These electrical pulses mask or interrupt pain signals as they travel up the spinal cord to the brain, reducing the sensation of pain.

Based in St. Paul, Minn., St. Jude Medical is a global medical device manufacturer focusing on cardiac rhythm management, atrial fibrillation, cardiovascular disease and neuromodulation.