Viveve announces FDA approval to continue VIVEVE II clinical study
Viveve Medical announced that it has received clearance from the U.S. Food and Drug Administration to continue enrollment in the company's multicenter randomized Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy clinical trial to assess the safety and effectiveness of the Viveve System for the improvement of sexual function in women following vaginal childbirth. The Agency's approval was based on a determination that the company provided sufficient data to support continued subject enrollment in the trial and that there are no subject protection concerns that preclude continuation of the study. "This clearance to continue enrollment represents a major step forward in the progression of the VIVEVE II trial and for women seeking an improvement in sexual function following child birth. Following FDA review of the second stage of safety data, and approval of an IDE supplement to expand the study, Viveve plans to continue enrollment up to 250 patients," stated CEO Scott Durbin.