BlueWind Medical has announced the availability of its Revi implantable Tibial NeuroModulation (iTNM) device for urge urinary incontinence (UUI) in Springfield, Ohio, US.
The patient-centric, minimally invasive solution is now offered at Ohio Valley Surgical Hospital.
It is controlled by a battery-operated external wearable unit and can be implanted near the ankle in a single outpatient procedure, performed under local anaesthesia.
The Revi iTNM implant aims to minimise potential adverse events associated with other surgical UUI therapies.
Once implanted, the Revi device works by stimulating the posterior tibial nerve to alleviate symptoms of UUI.
Patients can activate the implant using a lightweight wireless wearable that is placed around the ankle at their convenience, either once or twice daily, to provide the necessary stimulation.
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Ohio Valley Surgical Hospital urologist Dr Eric Espinosa said: “I am thrilled to have a new solution to offer patients with Urge Incontinence—a common condition that has a profound impact on quality of life. Revi is proven to be a safe and effective therapy, reducing the number of leaks patients have and it stands out for its patient-centric design, allowing for tailored adjustments to optimise therapy.
“My patients like the fact that Revi is placed in the ankle region in an outpatient procedure under local anaesthesia, which makes it a more appealing and convenient option for them.”
In August 2023, the US Food and Drug Administration (FDA) granted a De Novo marketing request for the device to treat patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
In October 2023, the American Medical Association CPT Editorial Panel announced the final Current Procedural Terminology code, 0817T, to describe the subfascial tibial neuromodulation implant procedure.
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.”
