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Viveve Medical, Inc., a medical technology company focused on women’s intimate health, announced the initiation of LIBERATE-International, a multicenter, randomized, double-blinded, sham-controlled trial to evaluate the safety and efficacy of its proprietary, cryogen-cooled monopolar radiofrequency (CMRF) technology for the improvement of stress urinary incontinence (SUI) in women. The first-subject-first-visit has now been completed under an approved Investigational Testing Application with the Canadian Ministry of Health and central investigational review board (IRB) approval.
“Initiation of LIBERATE-International represents a significant advance in our pursuit of regulatory clearances for the treatment of SUI, a condition that effects an estimated 25-30 million women worldwide. Our single-session procedure offers women the potential for significant improvement in urine leakage and quality of life. The results of LIBERATE-International, if successful, could support multiple international clearances for use of our CMRF technology in the treatment of SUI around the world, including Health Canada and CE Mark clearances, among others,” stated Scott Durbin, chief executive officer and director of Viveve.
In conjunction with initiation of the LIBERATE-International trial, Viveve also announced regulatory clearance in Argentina, for use of the Viveve® System, for the improvement of urinary incontinence.
“It is our belief that these clearances demonstrate continued regulatory confidence in the safety of our procedures and CMRF technology. As we continue our commitment towards rapid label expansion, we remain on track to complete the submission of our Investigational Device Exemption to the U.S. Food and Drug Administration (FDA) for LIBERATE-U.S., our second SUI registration trial, in the third quarter,” continued Mr. Durbin.
About the LIBERATE International Study
LIBERATE-International is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of approximately 100 subjects at up to ten study sites in Canada. Subjects will be randomized in a 2:1 ratio for active and sham treatments.
The primary efficacy endpoint is the mean change from baseline in the standardized 1-hour Pad Weight Test at six months post-treatment. The objective 1-hour Pad Weight Test is an FDA recommended endpoint. The study design also includes multiple exploratory endpoints, as well as, safety follow-up throughout the study.
For Further Information
More on the urological device market in the U.S. can be found in a series of reports published by iData Research entitled the U.S. Market Report Suite for Urological Devices. The suite covers reports on the following markets: urinary incontinence, stone management, BPH (benign prostate hyperplasia) treatment devices, urological endoscopes, prostate cancer, urodynamic equipment, nephrostomy and erectile dysfunction.
The iData report series on urological devices covers the U.S.and 15 countries in Europe including Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about urological market data or procedure data, register online or email us at [email protected] for a U.S. Market Report Suite for Urological Devices brochure and synopsis.