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Female physician sitting at desk with the Revi System talking to a female patient.
Female physician sitting at desk with the Revi System talking to a female patient.
Revi.

Unlocking a path forward for UUI

Female physician sitting at desk with the Revi System talking to a female patient.
Female physician sitting at desk with the Revi System talking to a female patient.

Transforming neuromodulation for urge urinary incontinence

BlueWind Revi® was crafted with the patient and the physicians who treat urge urinary incontinence (UUI) in mind. The advanced design of our implant for urinary incontinence allows for the device to be miniature in size without the need for replacement surgeries for battery change, lead migration, or lead fracture. Revi’s innovative external wearable technology powers the implant for a patient-centric approach to therapy, allowing for stimulation sessions based on the patients’ needs, without concern for energy consumption, while giving you the flexibility to ensure the best possible outcome.

In the OverActive Bladder Stimulation Study (OASIS) Completers analysis*  (N=139) at 12 months, Revi demonstrated:¹ 

95% of patients were satisfied with the treatment.

82% of patients had a ≥ 50% reduction in UUI episodes.

50% of patients were dry at 12 months on 3 consecutive diary days.

Revi System’s streamlined components

Revi implant.

Revi Implant is activated by a battery-operated external Wearable allowing it to be miniature in size at only 3 cm in length and 3 mm in diameter. This tibial implant delivers reliable and long-lasting performance in a compact form factor.

Revi wearable.

Revi Wearable is only 7.8 oz, delivering therapy at the patient’s convenience, when, where, and how often they want. Multiple treatment programs allow patients to adjust programs as needed.

Revi clinician programmer.

Revi Clinician Programmer allows for the customization of therapy based on a patient’s response. Includes adjustment of frequency, pulse width, polarity, and amplitude.

Revi hub.

Hub wirelessly communicates therapy data from the Wearable, allowing clinicians visibility into device usage and status to better support and optimize patient therapy.

Icon of MRI

The Revi Implant is MR conditional and is safe for 1.5T and 3T full body MR scans.

View the MRI Conditional Labeling
Hands holding a phone with the Revi patient app open.
Revi implant measurements. 3cm long, and 1.3cm full width while .27cm width on just the electrode.
Illustration displaying the placement of the implant on the tibial nerve near the ankle.
Hands holding a phone with the Revi patient app open.

myRevi App

Designed to help patients stay engaged and streamline patient support. Revi’s app-based tool provides:

  • Educational content to help inform and teach patients about urinary incontinence.
  • Online chat function to quickly answer questions and obtain system support.
  • Symptom tracking with surveys and voiding diary to monitor patient response.
Revi implant measurements. 3cm long, and 1.3cm full width while .27cm width on just the electrode.

Thoughtful design, miniaturized

This patented and novel miniature implant for urinary incontinence harnesses the power of modern wireless technology without the need for a bulky implant. It enables the battery to be externalized in the Wearable allowing for a more tailored treatment experience without concern for battery longevity.

Illustration displaying the placement of the implant on the tibial nerve near the ankle.

Single procedure, proven results

The unique implant placement and system design provides an alternative solution for patients seeking treatment:

  • Minimally Invasive. Miniature device is implanted in a single predictable procedure under local anesthesia.
  • Confident placement. Subfascial placement allows for direct visualization of the tibial nerve. Intraoperative testing and suture fixation provides for more predictable outcomes.
  • Customized therapy. Optimized treatment based on patient response. Dashboard allows provider visibility into device usage.
Revi implant inside an illustration of a keyhole.

Unlocking a
new path forward

Revi implant inside an illustration of a keyhole.

BlueWind Revi provides a key to UUI symptom relief for many patients and the healthcare providers who treat them. Surgeons should follow current clinical guidelines as applicable and should use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System. Stay connected to receive the latest updates about BlueWind Medical and Revi.

*Completers analysis represents the patients with available data at 12 months. Satisfaction results are from 130 patients.

For further information on the OASIS study and other on-going clinical studies, please visit clinicaltrials.gov (OASIS NCT03596671)

References

1. Heesakkers, J. et al. (2023, April 30). Pivotal Study of a Novel Wirelessly Powered, Patient Tailored Programmed, Tibial Neurostimulator for the Treatment of Patients with Overactive Bladder. AUA 2023.