The device is now available at Christus Surgery Center with urologist Gerard Henry and patients in the tri-state region of Louisiana, Arkansas, and Texas can now benefit from the device
Revi iTNM device is now available at Christus Surgery Center in Louisiana. (Credit: Online Marketing on Unsplash)
US-based neuro-stimulation device maker BlueWind Medical has introduced its Revi implantable Tibial NeuroModulation (iTNM) solution in Shreveport, Louisiana, US.
Revi is said to be the first US Food and Drug Administration (FDA) marketing authorised, battery-free tibial neuromodulation implant. It is designed for patients with urge urinary incontinence (UUI).
The device is now available at Christus Surgery Center with urologist Gerard Henry. The patients in the tri-state region of Louisiana, Arkansas, and Texas can now benefit from the device.
Revi iTNM has a miniature implant along with wearable technology to power the device. It is implanted close to the ankle during a single, outpatient operation under local anaesthesia.
According to BlueWind, the procedure does not have any potential adverse events, which are common with other surgical UUI therapies.
It is activated using a lightweight wireless wearable that is wrapped around the ankle once or twice a day to deliver stimulation at the patient’s convenience.
When activated, the implant relieves UUI by stimulating the posterior tibial nerve, the neuro-stimulation device maker said.
BlueWind Medical CEO Dan Lemaitre said: “We are delighted that this novel technology is now available in Shreveport with Dr Henry.
“Revi has the potential to revolutionise the treatment landscape for UUI by giving patients more control, comfort, and convenience.
“We are honoured to bring this life-changing technology to the millions of people who suffer from UUI and help them regain their confidence and dignity.”
With Revi, BlueWind has recently reached several milestones that show its dedication to patient care innovation.
In August this year, the US FDA approved a De Novo marketing request for the treatment of individuals exhibiting urgency incontinence symptoms either by themselves or in conjunction with urgency of urination.
The final Current Procedural Terminology (CPT) code for the subfascial tibial neuromodulation implant technique, 0817T, was revealed in October by the American Medical Association’s (AMA) CPT Editorial Panel.
The Revi device’s subfascial operations for tibial neuromodulation were paid for by the Centers for Medicare & Medicare Services (CMS) in November.