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FDA greenlights device to combat bladder issues
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Overactive bladder can be a debilitating condition — but those affected now have a new treatment option. Last week, the FDA authorized a small ankle implant with an accompanying wearable that provides stimulation, both built by BlueWind Medical. The stimulation, called tibial neuromodulation, blocks abnormal nerve signals around the bladder.
BlueWind tested its device on 151 women and found that around 75% of them responded to the therapy, experiencing 50% fewer bladder leaks. They recorded no adverse events. The company has not tested against a placebo control, CEO Dan Lemaitre said, because it didn’t have the money. But he plans to run one now that the implant is on the market.
“We are going to expand this market,” Lemaitre said. “We’re going to drive new patients into the treatment regimen. These are the folks that are sitting on the sidelines.”
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Tibial neuromodulation isn’t new, but it’s typically administered via an acupuncture-like needle in the clinic once a week — making it inconvenient for older patients. Sacral neuromodulation, which involves stimulating nerves near the pelvis, is a more effective option, but is more invasive.
“We see patients who are driving from three, four hours away,” said...
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