Viveve Announces FDA Approval of IDE to Conduct VIVEVE II Clinical Study

Viveve Medical (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, today announced it received approval of its Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA). The approval allows the company to conduct the VIveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) clinical trial to assess the safety and effectiveness of the Viveve® System for the improvement of sexual function in women following vaginal childbirth.

As quoted in the press release:

“The approval of our IDE enabling Viveve to proceed with the VIVEVE II clinical study is a major advancement in our global commercialization strategy and positions our CMRF (cryogen-cooled, monopolar radiofrequency) technology for a broader range of applications in women’s intimate health. The initiation of this study, which is expected to occur in the second quarter of 2018, underscores our continued commitment to conducting high-quality, scientific and clinical research, as demonstrated by our previous randomized, blinded and sham-controlled VIVEVE I clinical study, and by our planned randomized, blinded and sham-controlled LIBERATE studies in the U.S. and Canada for the treatment of stress urinary incontinence,” said Patricia Scheller, chief executive officer and director of Viveve.

Click here to read the full press release.