BlueWind Medical Receives FDA Clearance for Revi Extend Implant
Shots:
- The US FDA has granted 510(k) clearance to Revi Extend, the next-generation implant for Revi System to treat urgency urinary incontinence (UUI), with the new implant offering an extended lifespan of 15yrs.Limited US launch planned for Q4’26
- Built on Implantable Tibial Neuromodulation (ITNM), Revi System is designed to reduce the long-term treatment burden through personalized therapy, patient-controlled treatment, & a single minimally invasive procedure under local anesthesia with no trial phase
- Evaluated in the OASIS study, Revi System showed that 79% of pts achieved ≥50% reduction in UUI episodes, 63% achieved ≥75% reduction & 95% reported sustained therapeutic satisfaction through 3yrs.
Ref: Businesswire | Image: BlueWind Medical | Press Release
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