BlueWind Medical has introduced the supply of its implantable tibial neuromodulation (iTNM) system, Revi, in Shreveport, Louisiana, US.
The system is meant for sufferers affected by urge urinary incontinence (UUI).
Revi, claimed to be the one battery-free iTNM implant in the marketplace, is designed to supply a patient-centric answer for UUI.
Christus Surgical procedure Heart urologist Dr Gerard Henry is the primary to supply this remedy.
Henry stated: “Revi is a singular system that enables sufferers to manage their very own remedy and alter it to their particular person wants. It’s also a minimally invasive outpatient process that doesn’t require basic anaesthesia, which makes it extra handy and cozy for a lot of sufferers.”
The system, which is implanted close to the ankle in a single outpatient process underneath native anaesthesia, goals to mitigate the potential hostile occasions related to different surgical UUI therapies.
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It features a miniature implant and a wearable know-how element for system activation.
Sufferers can activate the Revi implant at their comfort, utilizing a light-weight wi-fi wearable positioned across the ankle a couple of times every day. This stimulation is meant to alleviate the signs of UUI successfully.
In August this yr, the US Meals and Drug Administration (FDA) granted a de novo advertising and marketing request for Revi for treating urgency incontinence signs.
Moreover, the American Medical Affiliation (AMA) CPT Editorial Panel has assigned a closing Present Procedural Terminology (CPT) code, 0817T, for the subfascial tibial neuromodulation implant process.
The Facilities for Medicare & Medicare Companies (CMS) finalised the power fee for subfascial procedures for tibial neuromodulation, together with these associated to the Revi system, with an unadjusted nationwide common of $20,854 for hospital outpatient providers, in November.
BlueWind Medical CEO Dan Lemaitre stated: “Revi has the potential to revolutionise the remedy panorama for UUI by giving sufferers extra management, consolation and comfort.”