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| Protégé MRI spinal cord stimulation (SCS) system--Courtesy of St. Jude Medical |
The FDA has approved the Protégé MRI spinal cord stimulation (SCS) system to treat chronic pain, along with the related MRI compatible leads, from St. Jude Medical ($STJ). The device also offers the benefit of enabling future updates via wireless software upgrades rather than requiring its replacement to gain the benefits of new developments.
The company expects that enabling patients in need of the device to have MR imaging and enabling upgrades via software could remove some hesitations they might experience about getting an SCS implant. St. Jude plans to further expand its MRI-compatible products by seeking updated labels for its Penta paddle lead, as well as for undisclosed future SCS systems.
Neuromodulation was St. Jude's smallest, but by far its fastest growing, business last quarter. With $108 million in sales, neuromodulation grew by 9% in the first quarter over the same quarter a year prior, or 14% on a constant-currency basis.
Earlier this month, St. Jude bought its neurostim partner Spinal Modulation for a total of at least $215 million (plus undisclosed approval and revenue milestones). It anticipates an FDA approval for the company's Axium Neurostimulator System to treat chronic pain by year end; St. Jude already markets the device in Europe through the prior partnership.
This year, neuromodulation is one of three pillars for St. Jude, achieving 4% to 5% revenue growth--and the company expects that in 2016, neuromodulation will be even stronger.
As for the Protégé MRI system, the company says it's the smallest MR-compatible SCS implantable pulse generator available in the U.S. It's also the only one that can receive future updates via software, rather than surgical replacement, that allows for MRIs.
"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 Dr. Robert Levy, director of the Marcus Neuroscience Institute in Boca Raton, FL, in a statement.
He added, "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."
- here is the release