The inFlow’s safety and effectiveness have been established by seven clinical studies published in major peer-reviewed journals (total n=501), including the pivotal trial that was the primary basis for FDA approval of the inFlow and six investigator-sponsored studies, three of which were long-term studies of between one and three years. For a review of these and other inFlow studies, please see inFlow evidence dossier.
The FDA has published its 2014 review of the inFlow and its pivotal trial. Please see FDA Report DEN130044.
The inFlow is also featured in a newly published and highly recommended textbook, The Underactive Bladder (Springer, 2016), edited by Drs. Michael Chancellor and Ananias Diokno. Please see http://www.springer.com/us/book/9783319236865