|Medtronic is studying a novel method of nerve stimulation with an eye on FDA approval.--Courtesy of Medtronic|
Medtronic ($MDT) is kicking off a large-scale study to expand the FDA indication for its subcutaneous nerve stimulation devices for chronic back pain.
The company's devices are already approved for spinal cord stimulation, in which leads reach all the way to the spinal column, but the company is looking to be the first to get FDA approval for peripheral nerve stimulation, a less-invasive approach to pain management using leads just under the skin.
In its latest study, dubbed SubQStim II, Medtronic is looking to recruit up to 323 patients at 30 sites around the country, testing whether its peripheral stimulation treatment can safely and effectively interrupt pain signals and improve outcomes for people who have undergone back surgery.
The company already has a CE mark to use its devices for subcutaneous back pain treatment around the globe, and expanding the method to treat the U.S.'s 100 million sufferers would significantly grow the market for the world's largest devicemaker.
"Chronic back pain affects a significant number of adults in the U.S., and if the SubQStim II pivotal trial results are positive, we plan to pursue FDA approval to make this potential treatment option available to patients who may benefit," Medtronic Pain Stimulation Vice President Julie Foster said in a statement.
The company isn't specifying when it plans to take its results to the FDA or when it expects agency approval, a spokeswoman said.
Medtronic is hardly alone in chasing an expanded share the multi-billion-dollar neurostimulation market. Boston Scientific ($BSX) touts Precision Spectra, its recently FDA-approved spinal cord stimulation device, as more effective than anything else on the market, and companies like Nevro, Neuros Medical and NeuroPace have raised millions in venture cash to market their pain-treating implants.
- read Medtronic's statement