BlueWind Medical has announced the availability of its implantable tibial neuromodulation (iTNM) device, Revi, in Shreveport, Louisiana, US.
The device is intended for patients suffering from urge urinary incontinence (UUI).
Revi, claimed to be the only battery-free iTNM implant on the market, is designed to provide a patient-centric solution for UUI.
Christus Surgery Center urologist Dr Gerard Henry is the first to offer this treatment.
Henry said: “Revi is a unique device that allows patients to control their own therapy and adjust it to their individual needs. It is also a minimally invasive outpatient procedure that does not require general anaesthesia, which makes it more convenient and comfortable for many patients.”
The device, which is implanted near the ankle in a single outpatient procedure under local anaesthesia, aims to mitigate the potential adverse events associated with other surgical UUI therapies.
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It includes a miniature implant and a wearable technology component for device activation.
Patients can activate the Revi implant at their convenience, using a lightweight wireless wearable placed around the ankle once or twice daily. This stimulation is intended to alleviate the symptoms of UUI effectively.
In August this year, the US Food and Drug Administration (FDA) granted a de novo marketing request for Revi for treating urgency incontinence symptoms.
Furthermore, the American Medical Association (AMA) CPT Editorial Panel has assigned a final Current Procedural Terminology (CPT) code, 0817T, for the subfascial tibial neuromodulation implant procedure.
The Centers for Medicare & Medicare Services (CMS) finalised the facility payment for subfascial procedures for tibial neuromodulation, including those related to the Revi device, with an unadjusted national average of $20,854 for hospital outpatient services, in November.
BlueWind Medical CEO Dan Lemaitre said: “Revi has the potential to revolutionise the treatment landscape for UUI by giving patients more control, comfort and convenience.”
