It is recommended that radiofrequency micro-remodeling with the Renessa® system meets CTAF criteria 1-5 for safety, effectiveness and improvement in health outcomes for the treatment of moderate to severe female stress urinary incontinence in non-pregnant women who are either not able or not willing to undergo surgery for their SUI treatment.

It is further recommended that radiofrequency micro-remodeling with the SURx ® system does not meet CTAF criteria 2-5 for safety, effectiveness and improvement in health outcomes for the treatment of female stress urinary incontinence.