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FDA Grants De Novo Request for Neuromodulatory System for Urge Incontinence

Three-fourths of patients had 50% reduction in incontinence at 6 months, 82% at 12 months

Duke university medical centerNorth carolinaUnited statesCharles bankheadCindyl amundsenTrevi systemBluewind medicalMedpage today

BlueWind Medical s Revi™ System Secures U S FDA De Novo Classification Grant for the Treatment of Urgency Incontinence

/PRNewswire/ BlueWind Medical, Ltd. today announced that the US Food and Drug Administration (FDA) granted a De Novo marketing request for the Revi System,.

United statesRoyt parkerCindyl amundsenJohn heesakkersDivision of urogynecologyAmerican urological associationDepartment of urology the maastrichtInternational continence societyBluewind medical ltdDrug administrationUrgency incontinenceBluewind medicalTrevi systemRevi implantDistinguished professorDuke university school

BlueWind Medical wins FDA nod for tibial neuromod implant

BlueWind Medical announced today that the FDA granted a de novo marketing request for its Revi neuromodulation system.

Royt parkerDan lemaitreCindyl amundsenDivision of urogynecologyUrology at duke university school of medicinePark cityUtah based bluewindBluewind medicalDistinguished professorDuke university school

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