Viveve Developing Device to Improve Sexual Function in Women

Viveve Health has received a nod from FDA to continue enrollment in a clinical trial to evaluate a technology to improve sexual function in women following vaginal childbirth. The Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) trial is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of about 250 patients at up to 25 study sites in the U.S. and Canada. The primary efficacy endpoint is intended to be the mean change from baseline in the total Female Sexual Function Index (FSFI) at 12 months. Subjects will also be assessed for safety over the 12 months. The approved protocol also includes a variety of secondary and exploratory endpoints measured at six months post-treatment that address the efficacy of and improvement in FSFI domain scores. The Englewood, CO.-based company said it could potentially submit to FDA for clearance in late 3Q19 or early 4Q19. “Vaginal laxity is the only first indication we’re going after,” Scott Durbin CEO of Viveve Medical, told MD+DI. “We’ve also announced pilot study results with the same therapy - applied in a different way- for improvement of pre-menopausal stress urinary incontinence (SUI). We have a submission with Health Canada for what we call LIBERATE international and that’s for an SUI indication. In the next 30 days we’re intending to submit a ...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news