junk098 wrote:Is rigicon infla even working on getting USA approval? Too small a company to bribe their way in? Their malleable was approved 6 yrs ago now. What are the urologist hearing?
https://academic.oup.com/jsm/article-ab ... ogin=false
Looks like as recently as December 2024 there was a USA paper published on the patient satisfaction and safety of the Rigicon Infla. I'm assuming that is part of the process to get FDA approved in the USA