BlueWind has breezed past a US Food and Drug Administration (FDA) clearance review, after the agency granted a de novo marketing request for BlueWind’s urinary incontinence system.
The system called Revi, is a type of neuromodulation therapy and has been greenlit for use by the FDA in men and women with urge urinary incontinence – a condition that causes an intense need to pass urine.
The device, originally called Renova, received CE marking in 2016 to treat overactive bladder. Now cleared for use in the US, BlueWind said that physicians can use the device if more conservative therapy proves fruitless.
The system comprises of an implant and a wearable ankle strap. The 3cm tall and 3mm wide implant is a battery-free device that is placed near the ankle in a minimally invasive procedure under local anaesthesia. The wireless ankle wearable provides accessible activation for the implant, upon which the small, inserted device stimulates the posterior tibial nerve.
BlueWind said the therapy should be done once to twice daily, which helps block electric signals along nerves to the brain that encode urinary urge. Also included in the product is the Revi Clinician Programmer, which provides therapy customisation options, and Revi Hub, responsible for data collection from the wearable.
The FDA based its decision on the OASIS clinical study (NCT03596671), the results of which BlueWind presented at the American Urological Association 2023 Annual Meeting held in Chicago 28 April – 1 May. The Utah, US-based company tested its system in 151 women with urge urinary incontinence.
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The trial met its primary endpoint – after six months of using the system, more than three-quarters of the participants had at least a 50% reduction in urge incontinence episodes. This number rose to 82% of subjects after a year. In those participants who completed the study, once-daily treatments sufficed just over 90% of the time. The company reported no serious procedure or device-related adverse events.
“It’s important that people living with the worry of urgent bladder leaks have a wider portfolio of options available to them sooner in their care pathway, including hassle-free, convenient options like Revi,” BlueWind CEO Dan Lemaitre told Medical Device Network.
“This is a critical step in ensuring thousands more people will be able live their lives without feeling limited by, or ashamed of, symptoms associated with urinary incontinence.”