** Shares of medical devices maker VIVE.O rise 12.3% to
$5.28 premarket
** VIVE says U.S. FDA approved its proposed changes to study
design of its pivotal trial testing efficacy of its
Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment for
stress urinary incontinence (SUI) in women urn:newsml:reuters.com:*:nACS1b1Dsa
** Co in October had submitted protocol amendments intended
to strengthen overall study to agency
** Plans to initiate trial in near future
** SUI refers to urine leakage during moments of physical
activity increasing abdominal pressure, such as coughing and
sneezing and is most common type of urinary incontinence in
women
** Up to Wednesday's close, stock down 62.7% YTD
(Reporting by Amruta Khandekar)
((Amruta.Khandekar@thomsonreuters.com;))